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1.  The Changes of Posterior Corneal Surface and High-Order Aberrations after Refractive Surgery in Moderate Myopia 
Purpose
To compare forward shift of posterior corneal surface and higher-order aberration (HOA) changes after LASIK, LASEK, and wavefront-guided LASEK surgery in moderate myopia
Methods
One hundred eighty four eyes undergoing LASIK, LASEK and wavefront-guided LASEK with VISX STAR S4 were included in this study. The posterior corneal elevation was measured with Orbscan before, 2 and 4 months after surgery. Changes of the elevation were assessed using the difference map generated from preoperative and postoperative elevation maps. The values of higher-order aberrations were evaluated preoperatively and 2 months postoperatively with Wavefront aberrometer.
Results
The posterior corneal surface displayed forward shift of 27.2±11.45 µm, 24.3±9.76 µm in LASIK group, 23.4±10.5 µm, 23.6±10.55 µm in LASEK group, 24.0±14.95 µm, 28.4±14.72 µm in wavefront-guided LASEK group at 2 months and 4 months, respectively. There were no statistically significant differences among those three groups, and between 2 and 4 months. The root mean score (RMS) of HOA was increased after LASIK and LASEK (p=0.000, p=0.000, respectively). The mean change of HOA-RMS was significantly smaller in wavefront-guided LASEK than LASIK or LASEK (p=0.000, p=0.000, respectively, Bonferroni-corrected).
Conclusions
The changes of posterior corneal surface forward shift showed no difference among LASIK, LASEK and wavefront-guided LASEK in moderate myopia. HOAs were significantly increased after LASIK and LASEK. The changes of HOAs were significant smaller in wavefront-guided LASEK than LASIK or LASEK.
doi:10.3341/kjo.2007.21.3.131
PMCID: PMC2629672  PMID: 17804916
Aberration; LASEK; LASIK; Posterior corneal surface; Wavefront-guided ablation
2.  Comparison of LASEK, mechanical microkeratome LASIK and Femtosecond LASIK in low and moderate myopia 
Saudi Journal of Ophthalmology  2013;28(3):214-219.
Purpose
We conducted a prospective study to determine the best treatment option for patients with low-to-moderate spherical myopia or myopic astigmatism who are considered equally eligible for LASEK with mitomycin-C (MMC) and LASIK with either mechanical microkeratome or femtosecond laser flap creation.
Methods
Forty-six adult patients (86 eyes) who underwent LASEK with MMC (16 patients, 31 eyes), and mechanical microkeratome LASIK (13 patients, 23 eyes) or Femtosecond LASIK (17 patients, 32 eyes) were assessed for clinical outcomes 1, 3 and 6 months post-operatively.
Results
Six months after surgery, all eyes in all three groups were within 1 D of the intended refractive change. UCVA 20/20 or better was achieved in 96% of eyes undergoing LASEK with MMC 88% of eyes in the mechanical microkeratome LASIK and 72% of eyes in the Femtosecond LASIK group at 6 months. Mean spherical equivalent was −0.12 ± 0.22 D, −0.09 ± 0.28 D and −0.25 ± 0.28 D in the three groups, respectively (p = 0.077). Patients in the LASEK with MMC group had less high order aberrations at 3 and 6 months compared to the two LASIK groups. None of the three procedures were associated with early- or late-onset complications or loss of 2 or more lines after surgery.
Conclusions
After an initially slower visual improvement, LASEK with MMC, and to lesser extent, LASIK with mechanical microkeratome, produced better visual acuity and less corneal aberrations compared to Femtosecond LASIK at 3 and 6 months after surgery. These observations deserve further investigation in a randomized controlled trial.
doi:10.1016/j.sjopt.2013.10.002
PMCID: PMC4181452  PMID: 25278800
Myopia; LASIK; LASEK; Mechanical microkeratome; Femtosecond laser
3.  Higher Order Aberrations of the Corneal Surface after Laser Subepithelial Keratomileusis 
Purpose
To evaluate the changes of higher order aberrations (HOAs) before and after laser subepithelial keratomileusis (LASEK) and to analyze the influence of tear film instability on HOAs of the corneal surface after LASEK.
Methods
In this cross-sectional study, 31 patients who underwent LASEK were divided into dry eye (16 patients, 32 eyes) and non-dry eye groups (15 patients, 30 eyes). Uncorrected distance visual acuity, spherical equivalent refraction, ablation depth, tear film parameters and Ocular Surface Disease Index (OSDI) questionnaire scores were evaluated in both groups. Total HOA root mean square (RMS), third-order coma, third-order trefoil and fourth-order spherical aberration (SA) of the corneal surface immediately and at 10 seconds after blinking were measured before and after surgery.
Results
The total HOA RMS, coma, trefoil and SA significantly increased after LASEK compared with preoperative values in both groups. In the dry eye group, total HOA RMS, coma and trefoil significantly increased except for SA at 10 seconds after blinking compared with those measured immediately after blinking. In addition, the changes of total HOA RMS, coma and trefoil were negatively correlated with tear film break-up time (R = -0.420, -0.473 and -0.439, respectively), but positively correlated with OSDI score (R = 0.433, 0.499 and 0.532, respectively). In the non-dry eye group, there were no significant differences between HOAs measured at 10 seconds after blinking and those measured immediately after blinking.
Conclusions
The HOAs including coma, trefoil and SA significantly increased after LASEK. The tear film instability in the dry eye can be associated with more deterioration of the optical quality after LASEK, due to more significant increase of total HOA RMS, coma and trefoil.
doi:10.3341/kjo.2014.28.4.285
PMCID: PMC4120348  PMID: 25120336
Higher order aberration; Laser subepithelial keratomileusis; Tear film instability
4.  Laser-Assisted Subepithelial Keratectomy versus Laser In Situ Keratomileusis in Myopia: A Systematic Review and Meta-Analysis 
ISRN Ophthalmology  2014;2014:672146.
This systematic review was to compare the clinical outcomes between laser-assisted subepithelial keratectomy (LASEK) and laser in situ keratomileusis (LASIK) for myopia. Primary parameters included mean manifest refraction spherical equivalent (MRSE), MRSE within ±0.50 diopters, uncorrected visual acuity (UCVA) ≥20/20, and loss of ≥1 line of best-corrected visual acuity (BCVA). Secondary parameters included flap complications and corneal haze. Twelve clinical controlled trials were identified and used for comparing LASEK (780 eyes) to LASIK (915 eyes). There were no significant differences in visual and refractive outcomes between the two surgeries for low to moderate myopia. The incidence of loss of ≥1 line of BCVA was significantly higher in moderate to high myopia treated by LASEK than LASIK in the mid-term and long-term followup. The efficacy (MRSE and UCVA) of LASEK appeared to be a significant worsening trend in the long-term followup. Corneal haze was more severe in moderate to high myopia treated by LASEK than LASIK in the mid-term and long-term followup. The flap-related complications still occurred in LASIK, but the incidence was not significantly higher than that in LASEK. LASEK and LASIK were safe and effective for low to moderate myopia. The advantage of LASEK was the absence of flap-related complications, and such procedure complication may occur in LASIK and affect the visual results. The increased incidence of stromal haze and regression in LASEK significantly affected the visual and refractive results for high myopia.
doi:10.1155/2014/672146
PMCID: PMC4058142  PMID: 24977054
5.  The SCHWIND AMARIS Total-Tech Laser as An All-Rounder in Refractive Surgery 
Purpose:
To describe and argument an overview of the main features and unique technical points of AMARIS Total-Tech Laser, coupled with patient outcomes supporting the decision to perform LASIK treatments with maximised outcomes.
Settings:
Dr. M.C. Arbelaez, Muscat Eye Laser Center, Muscat, Sultanate of Oman.
Methods:
The findings collected during 18-month experience using SCHWIND AMARIS Total-Tech Laser have been reviewed to provide arguments for supporting the decision to perform LASIK treatments with maximised outcomes. For updated clinical outcomes, the last 100 myopic astigmatism treatments, the last 100 hyperopic astigmatism treatments, the last 30 ocular-wavefront-guided treatments, and the last 30 corneal-wavefront-guided treatments, all with 6-month follow-up, were included. For all those, LDV femtosecond system was used to prepare the flaps, and AMARIS flying spot system was used to perform ablations. Clinical outcomes were evaluated in terms of predictability, refractive outcome, safety, wavefront aberration, and contrast sensitivity.
Results:
6-month postoperatively, mean defocus was −0.14±0.31D and astigmatism 0.25±0.37D. 70± eyes were within ±0.25D of emmetropia. 43± eyes gained lines of best spectacle-corrected visual acuity. For Aberration-Free treatments, none of the aberration metrics changed from pre- to postoperative values in a clinically relevant amount. For ocular-wavefront-guided treatments, the surgery did not change coma or spherical aberration, and reduced trefoil (p<0.005). For corneal-wavefront-guided treatments, the trefoil, coma, and spherical aberrations, as well as the total root-mean-square values of higher order aberration, were significantly reduced (p<.05) when the pre-existing aberrations were greater than the repeatability and the biological noise.
Conclusions:
Although this review does not allow for evidence-based conclusions, following our strategy, LASIK results were excellent. LASIK surgery with AMARIS system yield excellent outcomes. Refractions were reduced to subclinical values with no induction of High-Order-Aberrations. Neither adverse events nor complications were observed.
doi:10.4103/0974-9233.48868
PMCID: PMC2813579  PMID: 20142960
LASIK; Customized Treatments; Aspheric; Aberrations; Wavefront
6.  Laser intrastromal keratomileusis for high myopia and myopic astigmatism 
BACKGROUND—Laser intrastromal keratomileusis (LASIK) is an evolving technique which enables high degrees of myopia (>8.0 dioptres) and myopic astigmatism to be corrected. This paper describes initial experience with this procedure. It also details the methodology, the results, the problems encountered, and discusses retreatment procedures.
METHODS—51 eyes (48 primary cases and three retreatments) underwent LASIK for simple myopia or compound myopic astigmatism. After the keratotomy was fashioned with a Chiron corneal shaper, the ablation was performed with either a Summit or Meditec excimer laser. The actual preoperative astigmatism ranged from −0.5 D to −6.0 D (in the astigmatic myopic LASIK (AML) series), while the range of preoperative myopia in the combined myopic LASIK (ML) and AML series was −8.0 D to −37.0 D. Of the ML cases, group 1 (−8.0 to −15.0 D (dioptres)), group 2 (> −15.0 to −20.0 D), and group 3 (> −20.0 D) had mean preoperative myopia values (spherical equivalent) of −11.26 D, −16.84 D and −27.78 D. The same groupings (1, 2, and 3) for the AML cases had respective values of −9.702, −17.4, and −23.08. In the AML series the mean preoperative astigmatism was −2.109 D. Follow up ranged from 8 to 27 months (mean 15.8 months). Six of the cases required retreatment.
RESULTS—There was a reduction in best corrected visual acuity (BCVA) (of 1 Snellen line) in seven of the primary cases (14.5 %) (three in the ML group and four in the AML group), and in one of the retreatment cases. The BCVA improved in 28 cases (58%) in the primary treatment group. The mean correction attempted (spherical equivalent) for the ML groups 1, 2, and 3 was 10.51 D, −14.5 D, and −27.78 D, versus a mean correction achieved of −9.445 D, −15.625 D, and −21.571 D. Similarly, for the AML groups, attempted correction values were −9.702 D, −17.4 D, and −23.08 D, while the values achieved were −6.95 D, −51.425 D, and −15.708 D. Regression was minimal and stabilisation of the refractive result was achieved in all groups, except group 3 of the ML series, by the 3 month examination period. The mean postoperative astigmatism in the AML series was −0.531 D. Vector analysis of the AML series showed that the mean surgically induced astigmatism was +0.93 D. The most common complication encountered was undercorrection, which occurred in 35 cases—23 cases in the ML group and 12 cases in the AML series. Twenty eight per cent of the ML cases, and 25% of the AML cases were within plus or minus 1.5 D of the attempted refraction.
CONCLUSION—For the correction of high myopia and myopic astigmatism, LASIK results in less postoperative pain and relatively little subepithelial haze compared with high myopic photorefractive keratectomy. Furthermore, a stable refraction and reasonably predictable outcome occurs much earlier. High myopia up to −37.0 D can be corrected, albeit with some limitations at the extremes of myopia—in terms of the amount of myopia correctable; this represents a limitation of the technique. Retreatment is a technically straightforward and effective way to treat undercorrection. Undercorrection, the main complication seen in our series, should become less common when the ablation algorithms are further refined.


PMCID: PMC1722146  PMID: 9135383
7.  Changes in Spherical Aberration after Various Corneal Surface Ablation Techniques 
Purpose
The corneal change induced by refractive procedures influence both the postoperative refractive status and the ocular spherical aberration (SA). We evaluated changes in corneal SA after three types of surface ablation: phototherapeutic keratectomy (PTK), myopic photorefractive keratectomy (PRK), and myopic wavefront-guided laser epithelial keratomileusis (LASEK).
Methods
Twenty-six eyes (25 patients) were subjected to PTK 26 eyes (14 patients) to PRK, and 34 eyes (17 patients) to wavefront-guided LASEK. Corneal SA was measured with the iTrace in all patients both preoperatively and 6 months postoperatively.
Results
Six months after surgery, mean corneal SA was -0.173 ± 0.171 µm in the PTK group, 0.672 ± 0.200 µm in the PRK group, and 0.143 ± 0.136 µm in the wavefront-guided LASEK group. The mean difference between the preoperative and postoperative corneal SA (ΔSA) was -0.475 µm in the PTK group, 0.402 µm in the PRK group, and -0.143 µm in the wavefront-guided LASEK group.
Conclusions
Surgically induced changes in corneal SA vary with procedure. The prediction of the pattern of SA change induced by various surface ablation procedures may be helpful for developing future surgical procedures.
doi:10.3341/kjo.2013.27.2.81
PMCID: PMC3596623  PMID: 23543818
Aberration; Laser epithelial keratomileusis; Photorefractive keratectomy; Phototherapeutic keratectomy
8.  Higher-order aberrations after wavefront-optimized photorefractive keratectomy and laser in situ keratomileusis 
PURPOSE
To analyze the changes in higher-order aberrations (HOAs) that occur after wavefront-optimized photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK).
SETTING
Private practice, Atlanta, Georgia, USA.
METHODS
This retrospective analysis comprised eyes that had PRK or LASIK from June 2004 through October 2005. Postoperative outcome measures included 3-month uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), manifest refraction spherical equivalent (MRSE), changes in the root mean square (RMS) and grouped coefficient HOAs (microns) measured with a corneal analyzer, and subjective assessment of visual aberrations.
RESULTS
One hundred consecutive eyes of 54 patients had PRK, and 100 contemporaneous consecutive eyes of 71 patients had LASIK. The PRK and LASIK populations were similar in general demographics, preoperative HOAs, and postoperative UCVA and BSCVA. The mean MRSE was slightly hyperopic after PRK (mean +0.11 diopters [D]) and slightly myopic after LASIK (mean −0.19 D) (P<.0001). There were no statistically significant changes in RMS or grouped coefficient HOA values after PRK or LASIK, nor were there significant differences in postoperative RMS or grouped coefficient HOA values between PRK and LASIK. One percent of PRK and LASIK patients reported a subjective increase in postoperative visual aberrations; 5% reported a subjective improvement postoperatively.
CONCLUSIONS
Wavefront-optimized excimer laser surgery did not induce significant HOAs after PRK or LASIK. The 2 techniques were equally efficacious and had equivalent postoperative HOA profiles.
doi:10.1016/j.jcrs.2008.10.032
PMCID: PMC3750728  PMID: 19185240
9.  Six-month clinical outcomes after hyperopic correction with the SCHWIND AMARIS Total-Tech laser 
Journal of Optometry  2011;3(4):198-205.
Purpose
To evaluate postoperative clinical outcomes, and corneal High Order Aberrations, among eyes with hyperopia up to +5 D of spherical equivalent, that have undergone LASIK treatments using the SCHWIND AMARIS laser system.
Methods
At six-month follow-up, 100 eyes with preoperative hyperopia or hyperopic astigmatism up to +5 D of spherical equivalent were retrospectively analysed. Standard examinations, pre- and postoperative wavefront analysis with a corneal-wavefront-analyzer (OPTIKON Scout) were performed. Aberration-Free aspheric treatments were planned with Custom Ablation Manager software and ablations performed using the SCHWIND AMARIS flying-spot excimer laser system (both SCHWIND eye-tech-solutions). LASIK flaps were created using a LDV femtosecond laser (Ziemer Group) in all cases. Clinical outcomes were evaluated in terms of predictability, refractive outcome, safety, and wavefront aberration.
Results
At six month, 90 % of eyes achieved ≥ 20/25 UCVA and 44 % achieved ≥ 20/16 UCVA. Seventy-four percent of eyes were within ± 0.25D of spherical equivalent and 89 % within ± 0.50D, with 94 % within 0.50D of astigmatism. Mean spherical equivalent was −0.12 ± 0.51D and 0.50 ± 0.51D for the astigmatism. Fifty-two percent of eyes improved BSCVA vs. only 19 % losing lines of BSCVA. Predictability slope for refraction was 1.03 and intercept +0.01 D. On average, negative corneal spherical aberrations were significantly increased by the treatments, no other aberration terms changed from pre- to postoperative values.
Conclusions
LASIK for hyperopia and hyperopic astigmatism with SCHWIND AMARIS yields very satisfactory visual outcomes. Preoperative refractions were postoperatively reduced to subclinical values with no clinically relevant induction of corneal HOA.
doi:10.1016/S1888-4296(10)70029-7
PMCID: PMC3974390
Hyperopia; Refractive surgery; Excimer laser; Wavefront aberration; Aspheric ablation; Hipermetropía; Cirugía refractiva; Láser excimer; Aberración de frente de onda; Ablación asférica
10.  A prospective, randomized, fellow eye comparison of WaveLight® Allegretto Wave® Eye-Q versus VISX CustomVue™ STAR S4 IR™ in laser in situ keratomileusis (LASIK): analysis of visual outcomes and higher order aberrations 
Purpose
To compare outcomes in visual acuity, refractive error, higher-order aberrations (HOAs), contrast sensitivity, and dry eye in patients undergoing laser in situ keratomileusis (LASIK) using wavefront (WF) guided VISX CustomVue and WF optimized WaveLight Allegretto platforms.
Methods
In this randomized, prospective, single-masked, fellow eye study, LASIK was performed on 44 eyes (22 patients), with one eye randomized to WaveLight Allegretto, and the fellow eye receiving VISX CustomVue. Postoperative outcome measures at 3 months included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), refractive error, root-mean-square (RMS) value of total and grouped HOAs, contrast sensitivity, and Schirmers testing.
Results
Mean values for UDVA (logMAR) were −0.067 ± 0.087 and −0.073 ± 0.092 in the WF optimized and WF guided groups, respectively (P = 0.909). UDVA of 20/20 or better was achieved in 91% of eyes undergoing LASIK with both lasers while UDVA of 20/15 or better was achieved in 64% of eyes using the Allegretto platform, and 59% of eyes using VISX CustomVue (P = 1.000). In the WF optimized group, total HOA increased 4% (P = 0.012), coma increased 11% (P = 0.065), and spherical aberration increased 19% (P = 0.214), while trefoil decreased 5% (P = 0.490). In the WF guided group, total HOA RMS decreased 9% (P = 0.126), coma decreased 18% (P = 0.144), spherical aberration decreased 27% (P = 0.713) and trefoil decreased 19% (P = 0.660). One patient lost one line of CDVA secondary to residual irregular astigmatism.
Conclusion
Both the WaveLight Allegretto and the VISX CustomVue platforms had equal visual and safety outcomes. Most wavefront optimized HOA values trended upward, with a statistically significant increase in total HOA RMS. Eyes treated with the WF guided platform showed a decreasing trend in HOA values.
doi:10.2147/OPTH.S24316
PMCID: PMC3198407  PMID: 22034553
wavefront guided; wavefront optimized; laser in situ keratomileusis; LASIK; Allegretto; VISX
11.  Multi-aspheric description of the myopic cornea after different refractive treatments and its correlation with corneal higher order aberrations 
Journal of Optometry  2012;5(4):171-181.
Background
To analyse the asphericity of the anterior corneal surface (ACS) for different diameters, and correlate those values with corneal higher order aberrations (cHOA) before and after myopic treatments with corneal refractive therapy (CRT) for orthokeratology and customized (CL) and standard laser (SL) assisted in situ keratomileusis (LASIK).
Setting
Clínica Oftalmológica NovoVisión, Madrid, Spain.
Methods
The right eyes of 81 patients (27 in each treatment group), with a mean age of 29.94 ± 7.5 years, were analysed. Corneal videokeratographic data were used to obtain corneal asphericity (Q) for different corneal diameters from 3 to 8 mm and cHOA root mean square (RMS) obtained from Zernike polynomials for a pupil diameter of 6 mm.
Results
There were statistically significant differences in asphericity values calculated at different corneal diameters for different refractive treatments and their changes. The difference between asphericity at 3 and 8 mm reference diameters showed statistically significant correlations with spherical-like cHOA that was also significantly increased after all procedures.
Conclusions
The shift in corneal asphericity and the differences among different treatment techniques are more evident for the smaller reference diameters. These differences can be much reduced or even masked for a peripheral reference point at 4 mm from centre, which is used by some corneal topographers.
doi:10.1016/j.optom.2012.08.002
PMCID: PMC3860705
Laser assisted in situ keratomileusis (LASIK); Corneal asphericity; Corneal aberrations; Corneal refractive therapy; Queratomileusis in situ assistida por laser excimer (LASIK); Asfericidad corneal; Aberraciones corneales; Terapia refractiva corneal
12.  Visual performance after conventional LASIK and wavefront-guided LASIK with iris-registration: results at 1 year 
AIM
To compare visual performance of wavefront-guided laser in situ keratomileusis (LASIK) with iris-registration (Wg-LASIK group) and conventional LASIK (LASIK group) one year after surgery and analyze the correlation between wavefront aberrations and visual performance.
METHODS
Eight hundred and fifty-two myopic eyes of 430 patients were enrolled in this prospective study and divided into two groups: Wg-LASIK group (436 eyes) and LASIK group (416 eyes). A Wavescan Wavefront aberrometer was used to analyze Zernike coefficients and the root-mean-square (RMS) of higher order aberrations, and Optec 6500 visual function instrument was used to measure contrast sensitivity (CS) before and 3, 6, 12 months after surgery.
RESULTS
The mean spherical equivalent (SE) in Wg-LASIK group was significantly better than those in LASIK group one year after surgery (P=0.024). Wg-LASIK eyes showed better CS values than LASIK eyes at all spatial frequencies with and without glare after surgery (P all<0.01). Moreover, the increase of higher RMS (RMSh), coma, RMS3, RMS4, RMS5 in Wg-LASIK group were significantly lower than those in LASIK group 1 year after surgery (P all<0.05). The increase of coma, spherical aberration (SA), RMS3 and RMS4 in Wg-LASIK and coma and RMS3 in LASIK group were negatively correlated with reduction of contrast sensitivity 1 year after surgery.
CONCLUSION
A significant better visual performance is got in Wg-LASIK group compared with LASIK group 1 year after surgery, and the Wg-LASIK is particularly suitable for eyes with high-magnitude RMSh.
doi:10.3980/j.issn.2222-3959.2013.04.17
PMCID: PMC3755311  PMID: 23991386
aberration; contrast sensitivity; visual performance; laser in situ keratomileusis
13.  Aspheric Optical Zones in hyperopia with the SCHWIND AMARIS 
Journal of Optometry  2011;4(3):85-94.
Purpose
To evaluate the corneal Functional Optical Zone (FOZ) and the Effective Optical Zone (EOZ) of the ablation, among eyes that underwent LASEK/Epi-LASEK treatments for hyperopic astigmatism.
Methods
Twenty LASEK/Epi-LASEK treatments with mean defocus +2.21 ± 1.28 D performed using the SCHWIND AMARIS were retrospectively evaluated at 6-month follow-up. In all cases pre-/post-operative Corneal-Wavefront analyses using the Keratron-Scout (OPTIKON2000) were performed. FOZ-values were evaluated from the Root-Mean-Square of High-Order Wave-Aberration (RMSho), whereas EOZ-values were evaluated from the changes of Root-Mean-Square of High-Order Wave-Aberration (ΔRMSho) and Root-Mean-Square of the change of High-Order Wave-Aberration (RMS(ΔHOAb)). Correlations of FOZ and EOZ with Planned Optical Zone (POZ) and Defocus correction (SEq) were analyzed using a bilinear function.
Results
At six-month, defocus was −0.04 ± 0.44 D, ninety percent eyes were within ± 0.50 D from emmetropia. Mean RMSho increased 0.18 ± 0.22 μm, SphAb −0.30 ± 0.18 μm, and Coma 0.07 ± 0.18 μm 6-month after treatment (6-mm diameter). Mean FOZPre was 7.40 ± 1.48 mm, mean POZ was 6.76 ± 0.22 mm, whereas mean FOZPost was 5.53 ± 1.18 mm (significantly smaller, p < 0.0001; bilinear correlation p < 0.005), mean EOZΔRMSho 6.47 ± 1.17 mm (bilinear correlation p < 0.005), EOZRMS(ΔHOAb) 5.67 ± 1.23 mm (significantly smaller, p < 0.0005; bilinear correlation p < 0.05). EOZ positively correlates with POZ and declines steadily with SEq. A treatment of +3 D in 6.50-mm POZ results in 5.75-mm EOZ (7.75-mm NPOZ), treatments in 7.00-mm POZ result in about 6.25-mm EOZ (8.25-mm nomogrammed POZ).
Conclusions
FOZPost was significantly smaller than FOZPre. EOZΔRMSho was similar to POZ, whereas EOZRMS(ΔHOAb) was significantly smaller. Differences were larger for smaller POZ or larger Defocus. SEq up to +2 D result in EOZ, at least, as large as POZ. For SEq higher than +2 D, a nomogram for OZ can be applied.
doi:10.1016/S1888-4296(11)70047-4
PMCID: PMC3974388
Functional; Optical zone; Effective Optical Zona; Ablation; LASEK; Epi-LASEK; Hyperopic; Astigmatism; Wavefront; Aberration; Funcional; Zona óptica; Zona óptica eficaz; Ablación; LASEK; Epi-LASEK; Hipermetropía; Astigmatismo; Wavefront; Aberración
14.  Ocular higher-order aberrations and mesopic pupil size in individuals screened for refractive surgery 
AIM
To study the distribution of ocular higher-order aberrations(HOAs) and mesopic pupil size in individuals screened for refractive surgery.
METHODS
Ocular HOAs and mesopic pupil size were studied in 2 458 eyes of 1 240 patients with myopia, myopic astigmatism and compound myopic astigmatism and 215 eyes of 110 patients with hyperopia, hyperopic astigmatism and compound hyperopic astigmatism using the Zywave aberrometer (Busch& Lomb). All patients had correctable refractive errors without a history of refractive surgery or underlying diseases. Root-mean-square values of HOAs, total spherical aberration, total coma and mesopic pupil size were analyzed. Ocular HOAs were measured across a ≥ 6.0 mm pupil, and pupil size measurements were performed under the mesopic condition.
RESULTS
The mean values of HOAs, total spherical aberration and total coma in the myopic group were 0.369µm, ±0.233, 0.133± 0.112µm and 0.330±0.188µm, respectively. In the hyperopic group the mean values of HOAs, total spherical aberration and total coma were 0.418µm ±0.214, 0.202±0.209µm and 0.343±0.201µm, respectively. Hyperopes showed greater total HOAs (P<0.01) and total spherical aberration (P<0.01) compared to myopes. In age-matched analysis, only the amount of total spherical aberration was higher in the hyperopic group (P=0.05). Mesopic pupil size in the myopic group was larger (P≤0.05).
CONCLUSION
The results suggested that significant levels of HOAs were found in both groups which are important for planning refractive surgeries on Iranians. There were significantly higher levels of total spherical aberration in hyperopes compared to myopes. Mesopic pupil size was larger in myopic group.
doi:10.3980/j.issn.2222-3959.2012.02.21
PMCID: PMC3359043  PMID: 22762055
corneal wavefront aberration; pupil; mesopic vision; race; myopia; hyperopia
15.  Intrastromal Corneal Ring Implants for Corneal Thinning Disorders 
Executive Summary
Objective
The purpose of this project was to determine the role of corneal implants in the management of corneal thinning disease conditions. An evidence-based review was conducted to determine the safety, effectiveness and durability of corneal implants for the management of corneal thinning disorders. The evolving directions of research in this area were also reviewed.
Subject of the Evidence-Based Analysis
The primary treatment objectives for corneal implants are to normalize corneal surface topography, improve contact lens tolerability, and restore visual acuity in order to delay or defer the need for corneal transplant. Implant placement is a minimally invasive procedure that is purported to be safe and effective. The procedure is also claimed to be adjustable, reversible, and both eyes can be treated at the same time. Further, implants do not limit the performance of subsequent surgical approaches or interfere with corneal transplant. The evidence for these claims is the focus of this review.
The specific research questions for the evidence review were as follows:
Safety
Corneal Surface Topographic Effects:
Effects on corneal surface remodelling
Impact of these changes on subsequent interventions, particularly corneal transplantation (penetrating keratoplasty [PKP])
Visual Acuity
Refractive Outcomes
Visual Quality (Symptoms): such as contrast vision or decreased visual symptoms (halos, fluctuating vision)
Contact lens tolerance
Functional visual rehabilitation and quality of life
Patient satisfaction:
Disease Process:
Impact on corneal thinning process
Effect on delaying or deferring the need for corneal transplantation
Clinical Need: Target Population and Condition
Corneal ectasia (thinning) comprises a range of disorders involving either primary disease conditions such as keratoconus and pellucid marginal corneal degeneration or secondary iatrogenic conditions such as corneal thinning occurring after LASIK refractive surgery. The condition occurs when the normally round dome-shaped cornea progressively thins causing a cone-like bulge or forward protrusion in response to the normal pressure of the eye. Thinning occurs primarily in the stoma layers and is believed to be a breakdown in the collagen network. This bulging can lead to an irregular shape or astigmatism of the cornea and, because the anterior part of the cornea is largely responsible for the focusing of light on the retina, results in loss of visual acuity. This can make even simple daily tasks, such as driving, watching television or reading, difficult to perform.
Keratoconus (KC) is the most common form of corneal thinning disorder and is a noninflammatory chronic disease process. Although the specific causes of the biomechanical alterations that occur in KC are unknown, there is a growing body of evidence to suggest that genetic factors may play an important role. KC is a rare condition (<0.05% of the population) and is unique among chronic eye diseases as it has an early age of onset (median age of 25 years). Disease management for this condition follows a step-wise approach depending on disease severity. Contact lenses are the primary treatment of choice when there is irregular astigmatism associated with the disease. When patients can no longer tolerate contact lenses or when lenses no longer provide adequate vision, patients are referred for corneal transplant.
Keratoconus is one of the leading indications for corneal transplants and has been so for the last three decades. Yet, despite high graft survival rates of up to 20 years, there are reasons to defer receiving transplants for as long as possible. Patients with keratoconus are generally young and life-long term graft survival would be an important consideration. The surgery itself involves lengthy time off work and there are potential complications from long term steroid use following surgery, as well as the risk of developing secondary cataracts, glaucoma etc. After transplant, recurrent KC is possible with need for subsequent intervention. Residual refractive errors and astigmatism can remain challenging after transplantation and high refractive surgery rates and re-graft rates in KC patients have been reported. Visual rehabilitation or recovery of visual acuity after transplant may be slow and/or unsatisfactory to patients.
Description of Technology/Therapy
INTACS® (Addition Technology Inc. Sunnyvale, CA, formerly KeraVision, Inc.) are the only currently licensed corneal implants in Canada. The implants are micro-thin poly methyl methacrylate crescent shaped ring segments with a circumference arc length of 150 degrees, an external diameter of 8.10 mm, an inner diameter of 6.77 mm, and a range of different thicknesses. Implants act as passive spacers and, when placed in the cornea, cause local separation of the corneal lamellae resulting in a shortening of the arc length of the anterior corneal curvature and flattening the central cornea. Increasing segment thickness results in greater lamellar separation with increased flattening of the cornea correcting for myopia by decreasing the optical power of the eye. Corneal implants also improve corneal astigmatism but the mechanism of action for this is less well understood.
Treatment with corneal implants is considered for patients who are contact lens intolerant, having adequate corneal thickness particularly around the area of the implant incision site and without central corneal scarring. Those with central corneal scarring would not benefit from implants and those without an adequate corneal thickness, particularly in the region that the implants are being inserted, would be at increased risk for corneal perforation. Patients desiring to have visual rehabilitation that does not include glasses or contact lenses would not be candidates for corneal ring implants.
Placement of the implants is an outpatient procedure with topical anesthesia generally performed by either corneal specialists or refractive surgeons. It involves creating tunnels in the corneal stroma to secure the implants either by a diamond knife or laser calibrated to an approximate depth of 70% of the cornea. Variable approaches have been employed by surgeons in selecting ring segment size, number and position. Generally, two segments of equal thickness are placed superiorly and inferiorly to manage symmetrical patterns of corneal thinning whereas one segment may be placed to manage asymmetric thinning patterns.
Following implantation, the major safety concerns are for potential adverse events including corneal perforation, infection, corneal infiltrates, corneal neovascularization, ring migration and extrusion and corneal thinning. Technical results can be unsatisfactory for several reasons. Treatment may result in an over or under-correction of refraction and may induce astigmatism or asymmetry of the cornea.
Progression of the corneal cone with corneal opacities is also invariably an indication for progression to corneal transplant. Other reasons for treatment failure or patient dissatisfaction include foreign body sensation, unsatisfactory visual quality with symptoms such as double vision, fluctuating vision, poor night vision or visual side effects related to ring edge or induced or unresolved astigmatism.
Evidence-Based Analysis Methods
The literature search strategy employed keywords and subject headings to capture the concepts of 1) intrastromal corneal rings and 2) corneal diseases, with a focus on keratoconus, astigmatism, and corneal ectasia. The initial search was run on April 17, 2008, and a final search was run on March 6, 2009 in the following databases: Ovid MEDLINE (1996 to February Week 4 2009), OVID MEDLINE In-Process and Other Non-Indexed Citations, EMBASE (1980 to 2009 Week 10), OVID Cochrane Library, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment. Parallel search strategies were developed for the remaining databases. Search results were limited to human and English-language published between January 2000 and April 17, 2008. The resulting citations were downloaded into Reference Manager, v.11 (ISI Researchsoft, Thomson Scientific, U.S.A), and duplicates were removed. The Web sites of several other health technology agencies were also reviewed including the Canadian Agency for Drugs and Technologies in Health (CADTH), ECRI, and the United Kingdom National Institute for Clinical Excellence (NICE). The bibliographies of relevant articles were scanned.
Inclusion Criteria
English language reports and human studies
Any corneal thinning disorder
Reports with corneal implants used alone or in conjunction with other interventions
Original reports with defined study methodology
Reports including standardized measurements on outcome events such as technical success, safety, effectiveness, durability, vision quality of life or patient satisfaction
Case reports or case series for complications and adverse events
Exclusion Criteria
Non-systematic reviews, letters, comments and editorials
Reports not involving outcome events such as safety, effectiveness, durability, vision quality or patient satisfaction following an intervention with corneal implants
Reports not involving corneal thinning disorders and an intervention with corneal implants
Summary of Findings
In the MAS evidence review on intrastromal corneal ring implants, 66 reports were identified on the use of implants for management of corneal thinning disorders. Reports varied according to their primary clinical indication, type of corneal implant, and whether or not secondary procedures were used in conjunction with the implants. Implants were reported to manage post LASIK thinning and/or uncorrected refractive error and were also reported as an adjunctive intervention both during and after corneal transplant to manage recurrent thinning and/or uncorrected refractive error.
Ten pre-post cohort longitudinal follow-up studies were identified examining the safety and effectiveness of INTAC corneal implants in patients with keratoconus. Five additional cohort studies were identified using the Ferrara implant for keratoconus management but because this corneal implant is not licensed in Canada these studies were not reviewed.
The cohorts implanted with INTACS involved 608 keratoconus patients (754 eyes) followed for 1, 2 or 3 years. Three of the reports involved ≥ 2 years of follow-up with the longest having 5-year follow-up data for a small number of patients. Four of the INTAC cohort studies involved 50 or more patients; the largest involved 255 patients. Inclusion criteria for the studies were consistent and included patients who were contact lens intolerant, had adequate corneal thickness, particularly around the area of the implant incision site, and without central corneal scarring. Disease severity, thinning pattern, and corneal cone protrusions all varied and generally required different treatment approaches involving defined segment sizes and locations.
A wide range of outcome measures were reported in the cohort studies. High levels of technical success or ability to place INTAC segments were reported. Technically related complications were often delayed and generally reported as segment migration attributable to early experience. Overall, complications were infrequently reported and largely involved minor reversible events without clinical sequelae.
The outcomes reported across studies involved statistically significant and clinically relevant improvements in corneal topography, refraction and visual acuity, for both uncorrected and best-corrected visual acuity. Patients’ vision was usually restored to within normal functioning levels and for those not achieving satisfactory correction, insertion of intraocular lenses was reported in case studies to result in additional gains in visual acuity. Vision loss (infrequently reported) was usually reversed by implant exchange or removal. The primary effects of INTACS on corneal surface remodelling were consistent with secondary improvements in refractive error and visual acuity. The improvements in visual acuity and refractive error noted at 6 months were maintained at 1 and 2-year follow-up
Improvements in visual acuity and refractive error following insertion of INTACS, however, were not noted for all patients. Although improvements were not found to vary across age groups there were differences across stages of disease. Several reports suggested that improvements in visual acuity and refractive outcomes may not be as large or predictable in more advanced stages of KC. Some studies have suggested that the effects of INTACs were much greater in flattening the corneal surface than in correcting astigmatism. However, these studies involved small numbers of high risk patients in advanced stages of KC and conclusions made from this group are limited.
INTACS were used for other indications other than primary KC. The results of implant insertion on corneal topography, refraction, and visual acuity in post-LASIK thinning cases were similar to those reported for KC. The evidence for this indication, however, only involved case reports and small case series. INTACS were also successfully used to treat recurrent KC after corneal transplant but this was based on only a single case report. Corneal implants were compared to corneal transplantation but these studies were not randomized and based on small numbers of selected patients.
The foremost limitation of the evidence base is the basic study design in the reports that involved longitudinal follow-up only for the treated group; there were no randomized trials. Follow-up in the trials (although at prescribed intervals) often had incomplete accounts of losses at follow-up and estimates of change were often not reported or based on group differences. Second, although standardized outcome measures were reported, contact lens tolerance (a key treatment objective) was infrequently specified. A third general limitation was the lack of reporting of patients’ satisfaction with their vision quality or functional vision. Outcome measures for vision quality and impact on patient quality of life were available but rarely reported and have been noted to be a limitation in ophthalmological literature in general. Fourth, the longitudinal cohort studies have not followed patients long enough to evaluate the impact of implants on the underlying disease process (follow-up beyond 3 years is limited). Additionally, only a few of these studies directly examined corneal thinning in follow-up. The overall quality of evidence determined using the GRADE hierarchy of evidence was moderate.
There is some evidence in these studies to support the claim that corneal implants do not interfere with, or increase the difficultly of, subsequent corneal transplant, at least for those performed shortly after INTAC placement. Although it’s uncertain for how long implants can delay the need for a corneal transplant, given that patients with KC are often young (in their twenties and thirties), delaying transplant for any number of years may still be a valuable consideration.
Conclusion
The clinical indications for corneal implants have evolved from management of myopia in normal eyes to the management of corneal thinning disorders such as KC and thinning occurring after refractive surgery. Despite the limited evidence base for corneal implants, which consists solely of longitudinal follow-up studies, they appear to be a valuable clinical tool for improving vision in patients with corneal thinning. For patients unable to achieve functional vision, corneal implants achieved statistically significant and clinically relevant improvements in corneal topography, refraction, and visual acuity, providing a useful alternative to corneal transplant. Implants may also have a rescue function, treating corneal thinning occurring after refractive surgery in normal eyes, or managing refractive errors following corneal transplant. The treatment offers several advantages in that it’s an outpatient based procedure, is associated with minimal risk, and has high technical success rates. Both eyes can be treated at once and the treatment is adjustable and reversible. The implants can be removed or exchanged to improve vision without limiting subsequent interventions, particularly corneal transplant.
Better reporting on vision quality, functional vision and patient satisfaction, however, would improve evaluation of the impact of these devices. Information on the durability of the implants’ treatment effects and their affects on underlying disease processes is limited. This information is becoming more important as alternative treatment strategies, such as collagen cross-linking aimed at strengthening the underlying corneal tissue, are emerging and which might prove to be more effective or increase the effectiveness of the implants, particularly in advances stages of corneal thinning.
Ontario Health System Considerations
At present there are approximately 70 ophthalmologists in Canada who’ve had training with corneal implants; 30 of these practice in Ontario. Industry currently sponsors the training, proctoring and support for the procedure. The cost of the implant device ranges from $950 to $1200 (CAD) and costs for instrumentation range from $20,000 to $30,000 (CAD) (a one time capital expenditure). There is no physician services fee code for corneal implants in Ontario but assuming that they are no higher than those for a corneal transplant, the estimated surgical costs would be $914.32(CAD) An estimated average cost per patient, based on device costs and surgical fees, for treatment is $1,964 (CAD) (range $1,814 to $2,114) per eye. There have also been no out of province treatment requests. In Ontario the treatment is currently being offered in private clinics and an increasing number of ophthalmologists are being certified in the technique by the manufacturer.
KC is a rare disease and not all of these patients would be eligible candidates for treatment with corneal implants. Based on published population rates of KC occurrence, it can be expected that there is a prevalent population of approximately 6,545 patients and an incident population of 240 newly diagnosed cases per year. Given this small number of potential cases, the use of corneal implants would not be expected to have much impact on the Ontario healthcare system. The potential impact on the provincial budget for managing the incident population, assuming the most conservative scenario (i.e., all are eligible and all receive bilateral implants) ranges from $923 thousand to $1.1 million (CAD). This estimate would vary based on a variety of criteria including eligibility, unilateral or bilateral interventions, re-interventions, capacity and uptake
Keywords
Keratoconus, corneal implants, corneal topography, corneal transplant, visual acuity, refractive error
PMCID: PMC3385416  PMID: 23074513
16.  Comparison of prophylactic higher fluence corneal cross-linking to control, in myopic LASIK, one year results 
Purpose
To compare 1-year results: safety, efficacy, refractive and keratometric stability, of femtosecond myopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL) (LASIK-CXL).
Methods
We studied a total of 155 consecutive eyes planned for LASIK myopic correction. Group A represented 73 eyes that were treated additionally with concurrent prophylactic high-fluence CXL; group B included 82 eyes subjected to the stand-alone LASIK procedure. The following parameters were evaluated preoperatively and up to 1-year postoperatively: manifest refractive spherical equivalent (MRSE), refractive astigmatism, visual acuity, corneal keratometry, and endothelial cell counts. We plotted keratometry measurements pre-operatively and its change in the early, interim and later post-operative time for the two groups, as a means of keratometric stability comparison.
Results
Group A (LASIK-CXL) had an average postoperative MRSE of −0.23, −0.19, and −0.19 D for the 3-, 6-, and 12-month period, respectively, compared to −6.58±1.98 D preoperatively. Flat keratometry was 37.69, 37.66, and 37.67 D, compared to 43.94 D preoperatively, and steep keratometry was 38.35, 38.36, and 38.37 D, compared to 45.17 D preoperatively. The predictability of Manifest Refraction Spherical Equivalent (MRSE) correction showed a correlation coefficient of 0.979. Group B (stand-alone LASIK) had an average postoperative MRSE of −0.23, −0.20, and −0.27 D for the 3-, 6-, and 12-month period, respectively, compared with −5.14±2.34 D preoperatively. Flat keratometry was 37.65, 37.89, and 38.02 D, compared with 43.15 D preoperatively, and steep keratometry was 38.32, 38.57, and 38.66 D, compared with 44.07 D preoperatively. The predictability of MRSE correction showed a correlation coefficient of 0.970. The keratometric stability plots were stable for the LASIK CXL group and slightly regressing in the standard LASIK group, a novel stability evaluation metric that may escape routine acuity and refraction measurements.
Conclusion
Application of prophylactic CXL concurrently with myopic LASIK surgery appears to contribute to improved refractive and keratometric stability compared to standard LASIK. The procedure appears safe and provides a new potential for LASIK correction.
doi:10.2147/OPTH.S68372
PMCID: PMC4251572  PMID: 25473264
myopic LASIK regression; femtosecond myopic LASIK; LASIK-CXL; LASIK-Xtra; high myopia; accelerated high-fluence collagen cross-linking
17.  Spherical and aspherical photorefractive keratectomy and laser in-situ keratomileusis for moderate to high myopia: two prospective, randomized clinical trials. Summit technology PRK-LASIK study group. 
OBJECTIVE: Determine the outcomes of single-zone photorefractive keratectomy (SZPRK), aspherical photorefractive keratectomy (ASPRK), and laser in-situ keratomileusis (LASIK) for the correction of myopia between -6 and -12 diopters. DESIGN: Two simultaneous prospective, randomized, multi-center clinical trials. PARTICIPANTS: 286 first-treated eyes of 286 patients enrolled in one of two studies. In Study I, 134 eyes were randomized to SZPRK (58 eyes) or ASPRK (76 eyes). In Study II, 152 eyes were randomized to ASPRK (76 eyes) or to LASIK (76 eyes). INTERVENTION: All eyes received spherical one-pass excimer laser ablation as part of PRK or LASIK performed with the Summit Technologies Apex laser under an investigational device exemption, with attempted corrections between -6 and -12 diopters. MAIN OUTCOME MEASURES: Data on uncorrected and best spectacle-corrected visual acuity, predictability and stability of refraction, and complications were analyzed. Follow-up was 12 months. RESULTS: At 1 month postoperatively, more eyes in the LASIK group achieved 20/20 and 20/25 or better uncorrected visual acuity than PRK-treated eyes; at the 20/25 or better level, the difference was significant for LASIK (29/76 eyes, 38%) over SZPRK (10/58 eyes, 17%) (P = .0064). At all subsequent postoperative intervals, no difference was seen between treatment groups. Similarly, best corrected visual acuities were better for LASIK than all PRK eyes at 1 month postoperatively, and LASIK was better than SZPRK at 3 months follow-up (e.g., for 20/20 or better at 1 month, LASIK 50/76 eyes (66%) versus SZPRK 24/57 eyes (42%), P = .0066). PRK eyes had a mean loss of BCVA through 6 months, while LASIK eyes had a slight gain of mean BCVA through month 6; at 12 months, both ASPRK groups but not SZPRK continued to have a small mean loss of BCVA (e.g., compared to preoperative, mean BCVA at 12 months for SZPRK was + 0.3, LASIK was +.21, ASPRK I was -0.11, and ASPRK II -0.31 (SZPRK versus ASPRK II, P = .0116). Predictability was better for PRK than LASIK at all follow-up intervals (e.g., for manifest refraction spherical equivalent +/- 1.0 diopters at 6 months, ASPRK I 42/62 eyes (68%) versus LASIK 29/72 eyes (40%), P = .0014%). Stability was slightly but insignificantly less in the LASIK eyes compared to PRK eyes. All visual outcome measures were better for eyes with preoperative myopia between -6 and -8.9 D compared with eyes with myopia between -9 and -12 D. No consistent differences in refractive outcomes or postoperative corneal haze were seen between aspherical and single-zone ablations; haze diminished over 12 months and was judged to be vision-impairing in only one ASPRK eye. Microkeratome and flap complications occurred in 4 eyes, resulting in delay of completion of the procedure in 3 eyes but not causing long-term impairment. CONCLUSIONS: Improvement in uncorrected visual acuity and return of best corrected visual acuity was more rapid for LASIK than PRK, but efficacy outcomes in the longer term through 12 months were similar for all treatment groups. LASIK eyes tended toward undercorrection with the nomogram employed in this study compared to PRK, but the scatter was similar, suggesting little difference between these procedures for most patients by 6 months and thereafter. No consistent advantage was demonstrated between aspherical and single-zone ablation patterns. Predictability was much better for all procedures for corrections of -6 to -8.9 D compared with -9 to -12 D. Sporadic loss of best corrected vision in the PRK eyes not found in the LASIK eyes and other measures of visual function require further study.
PMCID: PMC1298396  PMID: 10360290
18.  Wavefront-Guided Laser in Situ Keratomileusis (Lasik) versus Wavefront-Guided Photorefractive Keratectomy (Prk): A Prospective Randomized Eye-to-Eye Comparison (An American Ophthalmological Society Thesis) 
Purpose
To compare the safety and efficacy of wavefront-guided laser in situ keratomileusis (LASIK) vs photorefractive keratectomy (PRK) in a prospective randomized clinical trial.
Methods
A cohort of 68 eyes of 34 patients with −0.75 to −8.13 diopters (D) of myopia (spherical equivalent) were randomized to receive either wavefront-guided PRK or LASIK in the fellow eye using the VISX CustomVue laser. Patients were evaluated at 1 day, 1 week, and months 1, 3, 6, and 12.
Results
At 1 month, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), 5% and 25% contrast sensitivity, induction of higher-order aberrations (HOAs), and subjective symptoms of vision clarity, vision fluctuation, ghosting, and overall self-assessment of vision were worse (P<0.05) in the PRK group. By 3 months, these differences had resolved (P>0.05). At 1 year, mean spherical equivalent was reduced 94% to −0.27 ± 0.31 D in the LASIK group and reduced 96% to −0.17 ± 0.41 D in the PRK group. At 1 year, 91% of eyes were within ±0.50 D and 97 % were within ±1.0 D in the PRK group. At 1 year, 88% of eyes were within ±0.50 D and 97% were within ±1.0 D in the LASIK group. At 1 year, 97% of eyes in the PRK group and 94% of eyes in the LASIK group achieved an UCVA of 20/20 or better (P=0.72). Refractive stability was achieved in both PRK and LASIK groups after 1 month. There were no intraoperative or postoperative flap complications in the LASIK group. There were no instances of corneal haze in the PRK group.
Conclusions
Wavefront-guided LASIK and PRK are safe and effective at reducing myopia. At 1 month postoperatively, LASIK demonstrates an advantage over PRK in UCVA, BSCVA, low-contrast acuity, induction of total HOAs, and several subjective symptoms. At postoperative month 3, these differences between PRK and LASIK results had resolved.
PMCID: PMC3259671  PMID: 22253488
19.  Collagen Cross-Linking Using Riboflavin and Ultraviolet-A for Corneal Thinning Disorders 
Executive Summary
Objective
The main objectives for this evidence-based analysis were to determine the safety and effectiveness of photochemical corneal collagen cross-linking with riboflavin (vitamin B2) and ultraviolet-A radiation, referred to as CXL, for the management of corneal thinning disease conditions. The comparative safety and effectiveness of corneal cross-linking with other minimally invasive treatments such as intrastromal corneal rings was also reviewed. The Medical Advisory Secretariat (MAS) evidence-based analysis was performed to support public financing decisions.
Subject of the Evidence-Based Analysis
The primary treatment objective for corneal cross-linking is to increase the strength of the corneal stroma, thereby stabilizing the underlying disease process. At the present time, it is the only procedure that treats the underlying disease condition. The proposed advantages for corneal cross-linking are that the procedure is minimally invasive, safe and effective, and it can potentially delay or defer the need for a corneal transplant. In addition, corneal cross-linking does not adversely affect subsequent surgical approaches, if they are necessary, or interfere with corneal transplants. The evidence for these claims for corneal cross-linking in the management of corneal thinning disorders such as keratoconus will be the focus of this review.
The specific research questions for the evidence review were as follows:
Technical: How technically demanding is corneal cross-linking and what are the operative risks?
Safety: What is known about the broader safety profile of corneal cross-linking?
Effectiveness - Corneal Surface Topographic Affects:
What are the corneal surface remodeling effects of corneal cross-linking?
Do these changes interfere with subsequent interventions, particularly corneal transplant known as penetrating keratoplasty (PKP)?
Effectiveness -Visual Acuity:
What impacts does the remodeling have on visual acuity?
Are these impacts predictable, stable, adjustable and durable?
Effectiveness - Refractive Outcomes: What impact does remodeling have on refractive outcomes?
Effectiveness - Visual Quality (Symptoms): What impact does corneal cross-linking have on vision quality such as contrast vision, and decreased visual symptoms (halos, fluctuating vision)?
Effectiveness - Contact lens tolerance: To what extent does contact lens intolerance improve after corneal cross-linking?
Vision-Related QOL: What is the impact of corneal cross-linking on functional visual rehabilitation and quality of life?
Patient satisfaction: Are patients satisfied with their vision following the procedure?
Disease Process:
What impact does corneal cross-linking have on the underling corneal thinning disease process?
Does corneal cross-linking delay or defer the need for a corneal transplant?
What is the comparative safety and effectiveness of corneal cross-linking compared with other minimally invasive treatments for corneal ectasia such as intrastromal corneal rings?
Clinical Need: Target Population and Condition
Corneal ectasia (thinning) disorders represent a range of disorders involving either primary disease conditions, such as keratoconus (KC) and pellucid marginal corneal degeneration, or secondary iatrogenic conditions, such as corneal thinning occurring after laser in situ keratomileusis (LASIK) refractive surgery.
Corneal thinning is a disease that occurs when the normally round dome-shaped cornea progressively thins causing a cone-like bulge or forward protrusion in response to the normal pressure of the eye. The thinning occurs primarily in the stroma layers and is believed to be a breakdown in the collagen process. This bulging can lead to irregular astigmatism or shape of the cornea. Because the anterior part of the cornea is responsible for most of the focusing of the light on the retina, this can then result in loss of visual acuity. The reduced visual acuity can make even simple daily tasks, such as driving, watching television or reading, difficult to perform.
Keratoconus is the most common form of corneal thinning disorder and involves a noninflammatory chronic disease process of progressive corneal thinning. Although the specific cause for the biomechanical alterations in the corneal stroma is unknown, there is a growing body of evidence suggesting that genetic factors may play an important role. Keratoconus is a rare disease (< 0.05% of the population) and is unique among chronic eye diseases because it has an early onset, with a median age of 25 years. Disease management for this condition follows a step-wise approach depending on disease severity. Contact lenses are the primary treatment of choice when there is irregular astigmatism associated with the disease. Patients are referred for corneal transplants as a last option when they can no longer tolerate contact lenses or when lenses no longer provide adequate vision.
Keratoconus is one of the leading indications for corneal transplants and has been so for the last 3 decades. Despite the high success rate of corneal transplants (up to 20 years) there are reasons to defer it as long as possible. Patients with keratoconus are generally young and a longer-term graft survival of at least 30 or 40 years may be necessary. The surgery itself involves lengthy time off work and postsurgery, while potential complications include long-term steroid use, secondary cataracts, and glaucoma. After a corneal transplant, keratoconus may recur resulting in a need for subsequent interventions. Residual refractive errors and astigmatism can remain challenges after transplantation, and high refractive surgery and regraft rates in KC patients have been reported. Visual rehabilitation or recovery of visual acuity after transplant may be slow and/or unsatisfactory to patients.
Description of Technology/Therapy
Corneal cross-linking involves the use of riboflavin (vitamin B2) and ultraviolet-A (UVA) radiation. A UVA irradiation device known as the CXL® device (license number 77989) by ACCUTECH Medical Technologies Inc. has been licensed by Health Canada as a Class II device since September 19, 2008. An illumination device that emits homogeneous UVA, in combination with any generic form of riboflavin, is licensed by Health Canada for the indication to slow or stop the progression of corneal thinning caused by progressive keratectasia, iatrogenic keratectasia after laser-assisted in situ keratomileusis (LASIK) and pellucid marginal degeneration. The same device is named the UV-X® device by IROCMedical, with approvals in Argentina, the European Union and Australia.
UVA devices all use light emitting diodes to generate UVA at a wavelength of 360-380 microns but vary in the number of diodes (5 to 25), focusing systems, working distance, beam diameter, beam uniformity and extent to which the operator can vary the parameters. In Ontario, CXL is currently offered at over 15 private eye clinics by refractive surgeons and ophthalmologists.
The treatment is an outpatient procedure generally performed with topical anesthesia. The treatment consists of several well defined procedures. The epithelial cell layer is first removed, often using a blunt spatula in a 9.0 mm diameter under sterile conditions. This step is followed by the application of topical 0.1% riboflavin (vitamin B2) solution every 3 to 5 minutes for 25 minutes to ensure that the corneal stroma is fully penetrated. A solid-state UVA light source with a wavelength of 370 nm (maximum absorption of riboflavin) and an irradiance of 3 mW/cm2 is used to irradiate the central cornea. Following treatment, a soft bandage lens is applied and prescriptions are given for oral pain medications, preservative-free tears, anti-inflammatory drops (preferably not nonsteroidal anti-inflammatory drugs, or NSAIDs) and antibiotic eye drops. Patients are recalled 1 week following the procedure to evaluate re-epithelialization and they are followed-up subsequently.
Evidence-Based Analysis Methods
A literature search was conducted on photochemical corneal collagen cross-linking with riboflavin (vitamin B2) and ultraviolet-A for the management of corneal thinning disorders using a search strategy with appropriate keywords and subject headings for CXL for literature published up until April 17, 2011. The literature search for this Health Technology Assessment (HTA) review was performed using the Cochrane Library, the Emergency Care Research Institute (ECRI) and the Centre for Reviews and Dissemination. The websites of several other health technology agencies were also reviewed, including the Canadian Agency for Drugs and Technologies in Health (CADTH) and the United Kingdom’s National Institute for Clinical Excellence (NICE). The databases searched included OVID MEDLINE, MEDLINE IN-Process and other Non-Indexed Citations such as EMBASE.
As the evidence review included an intervention for a rare condition, case series and case reports, particularly for complications and adverse events, were reviewed. A total of 316 citations were identified and all abstracts were reviewed by a single reviewer for eligibility. For those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
English-language reports and human studies
patients with any corneal thinning disorder
reports with CXL procedures used alone or in conjunction with other interventions
original reports with defined study methodology
reports including standardized measurements on outcome events such as technical success, safety effectiveness, durability, vision quality of life or patient satisfaction
systematic reviews, meta-analyses, randomized controlled trials, observational studies, retrospective analyses, case series, or case reports for complications and adverse events
Exclusion Criteria
nonsystematic reviews, letters, comments and editorials
reports not involving outcome events such as safety, effectiveness, durability, vision quality or patient satisfaction following an intervention with corneal implants
reports not involving corneal thinning disorders and an intervention involving CXL
Summary of Evidence Findings
In the Medical Advisory Secretariat evidence review on corneal cross-linking, 65 reports (16 case reports) involving 1403 patients were identified on the use of CXL for managing corneal thinning disorders. The reports were summarized according to their primary clinical indication, whether or not secondary interventions were used in conjunction with CXL (referred to as CXL-Plus) and whether or not it was a safety-related report.
The safety review was based on information from the cohort studies evaluating effectiveness, clinical studies evaluating safety, treatment response or recovery, and published case reports of complications. Complications, such as infection and noninfectious keratitis (inflammatory response), reported in case reports, generally occurred in the first week and were successfully treated with topical antibiotics and steroids. Other complications, such as the cytotoxic effects on the targeted corneal stroma, occurred as side effects of the photo-oxidative process generated by riboflavin and ultraviolet-A and were usually reversible.
The reports on treatment effectiveness involved 15 pre-post longitudinal cohort follow-up studies ranging from follow-up of patients’ treated eye only, follow-up in both the treated and untreated fellow-eye; and follow-up in the treated eye only and a control group not receiving treatment. One study was a 3-arm randomized control study (RCT) involving 2 comparators: one comparator was a sham treatment in which one eye was treated with riboflavin only; and the other comparator was the untreated fellow-eye. The outcomes reported across the studies involved statistically significant and clinically relevant improvements in corneal topography and refraction after CXL. In addition, improvements in treated eyes were accompanied by worsening outcomes in the untreated fellow-eyes. Improvements in corneal topography reported at 6 months were maintained at 1- and 2-year follow-up. Visual acuity, although not always improved, was infrequently reported as vision loss. Additional procedures such as the use of intrastromal corneal ring segments, intraocular lenses and refractive surgical practices were reported to result in additional improvements in topography and visual acuity after CXL.
Considerations for Ontario Health System
The total costs of providing CXL therapy to keratoconus patients in Ontario was calculated based on estimated physician, clinic, and medication costs. The total cost per patient was approximately $1,036 for the treatment of one eye, and $1,751 for the treatment of both eyes. The prevalence of keratoconus was estimated at 4,047 patients in FY2011, with an anticipated annual incidence (new cases) of about 148 cases. After distributing the costs of CXL therapy for the FY2011 prevalent keratoconus population over the next 3 years, the estimated average annual cost was approximately $2.1 million, of which about $1.3 million would be physician costs specifically.
Conclusion
Corneal cross-linking effectively stabilizes the underlying disease, and in some cases reverses disease progression as measured by key corneal topographic measures. The affects of CXL on visual acuity are less predictable and the use of adjunct interventions with CXL, such as intrastromal corneal ring segments, refractive surgery, and intraocular lens implants are increasingly employed to both stabilize disease and restore visual acuity. Although the use of adjunct interventions have been shown to result in additional clinical benefit, the order, timing, and risks of performing adjunctive interventions have not been well established.
Although there is potential for serious adverse events with corneal UVA irradiation and photochemical reactions, there have been few reported complications. Those that have occurred tended to be related to side effects of the induced photochemical reactions and were generally reversible. However, to ensure that there are minimal complications with the use of CXL and irradiation, strict adherence to defined CXL procedural protocols is essential.
Keywords
Keratoconus, corneal cross-linking, corneal topography, corneal transplant, visual acuity, refractive error.
PMCID: PMC3377552  PMID: 23074417
20.  CORNEAL ABERRATIONS AND VISUAL ACUITY AFTER LASIK: FEMTOSECOND LASER VERSUS MECHANICAL MICROKERATOME 
American journal of ophthalmology  2010;149(5):785-793.
Purpose
To compare corneal high-order aberrations and visual acuity after LASIK with the flap created by a femtosecond laser (bladeless) to LASIK with the flap created by a mechanical microkeratome.
Design
Prospective, randomized, paired-eye study.
Methods
Fellow eyes of 21 patients with myopia or myopic astigmatism were randomized by ocular dominance. Corneal topography and visual acuity were measured before and at 1, 3, 6, 12 and 36 months after LASIK. Wavefront errors from the anterior corneal surface were calculated from the topography data over 4- and 6-mm-dimater pupils and decomposed into Zernike polynomials to the 6th order.
Results
There were no differences in corneal total high-order aberrations, spherical aberration, coma or trefoil between methods of flap creation at any examination over 4-and 6-mm-diameter pupils. Over a 6 mm pupil, total high-order aberrations increased by 1 month after LASIK with both treatments (p≤0.001) and remained increased through 36 months (p≤0.001). Uncorrected and best-corrected visual acuity did not differ between methods at any examination and remained stable postoperatively through 3 years; the minimum detectable difference in visual acuity between treatments was ≤0.1 logMAR (≤1 line of vision, α=0.05/6, β=0.20, n=21).
Conclusions
The planar configuration of the femtosecond laser flap did not offer any advantage in corneal high-order aberrations or visual acuity through 3 years after LASIK. Corneal high-order aberrations remain stable through 3 ears after LASIK.
doi:10.1016/j.ajo.2009.12.023
PMCID: PMC2856792  PMID: 20227675
21.  Visual outcome after correcting the refractive error of large pupil patients with wavefront-guided ablation 
Purpose
To investigate the efficacy and predictability of wavefront-guided laser in situ keratomileusis (LASIK) treatments using the iris registration (IR) technology for the correction of refractive errors in patients with large pupils.
Setting
Horus Vision Correction Center, Alexandria, Egypt.
Methods
Prospective noncomparative study including a total of 52 eyes of 30 consecutive laser refractive correction candidates with large mesopic pupil diameters and myopia or myopic astigmatism. Wavefront-guided LASIK was performed in all cases using the VISX STAR S4 IR excimer laser platform. Visual, refractive, aberrometric and mesopic contrast sensitivity (CS) outcomes were evaluated during a 6-month follow-up.
Results
Mean mesopic pupil diameter ranged from 8.0 mm to 9.4 mm. A significant improvement in uncorrected distance visual acuity (UCDVA) (P < 0.01) was found postoperatively, which was consistent with a significant refractive correction (P < 0.01). No significant change was detected in corrected distance visual acuity (CDVA) (P = 0.11). Efficacy index (the ratio of postoperative UCDVA to preoperative CDVA) and safety index (the ratio of postoperative CDVA to preoperative CDVA) were calculated. Mean efficacy and safety indices were 1.06 ± 0.33 and 1.05 ± 0.18, respectively, and 92.31% of eyes had a postoperative spherical equivalent within ±0.50 diopters (D). Manifest refractive spherical equivalent improved significantly (P < 0.05) from a preoperative level of −3.1 ± 1.6 D (range −6.6 to 0 D) to −0.1 ± 0.2 D (range −1.3 to 0.1 D) at 6 months postoperative. No significant changes were found in mesopic CS (P ≥ 0.08), except CS for three cycles/degree, which improved significantly (P = 0.02). Magnitudes of primary coma and trefoil did not change significantly (P ≥ 0.34), with a small but statistically significant increase in primary spherical aberration.
Conclusion
Wavefront-guided LASIK provides an effective correction of low to moderate myopia or myopic astigmatism in large pupil patients without deterioration of visual quality.
doi:10.2147/OPTH.S38182
PMCID: PMC3526903  PMID: 23271878
large pupil; wavefront; LASIK
22.  Comparison of high order aberration after conventional and customized ablation in myopic LASIK in different eyes of the same patient 
Purpose: To verify whether there exists any difference in higher order aberrations after undergoing myopic LASIK (laser in situ keratomileusis) with conventional ablation and customized ablation in different eyes of the same patient. Methods: This was a prospective randomized study of 54 myopic eyes (27 patients) that underwent LASIK using the Nidek EC-5000 excimer laser system (Nidek, Gamagori, Japan). Topography-guided customized aspheric treatment zone (CATz) was used in the first eye of the patient (study group) and the other eye of the same patient was operated on with conventional ablation (control group). Higher order aberrations [root-mean-square (RMS) in the 5-mm zone] of both groups were observed with the Nidek OPD-Scan aberrometer before and 3 months after LASIK. Preoperative mean refractive error was similar between two eyes of the same patient (t=−0.577, P>0.05). Results: Preoperatively, higher order aberrations (RMS in the 5-mm zone) in the CATz ablation and conventional groups were (0.3600±0.0341) µm and (0.2680±0.1421) µm, respectively. This difference was not statistically significant (t=1.292, P>0.05). Three months after LASIK, higher order aberrations (RMS in 5-mm zone) in the CATz ablation and conventional groups were (0.3627±0.1510) µm and (0.3991±0.1582) µm, respectively. No statistically significant difference was noted between pre- and postoperative higher order aberrations in the CATz group (t=−0.047, P>0.05). However, a statistically significant increase in higher order aberrations was observed after conventional ablation (t=−5.261, P<0.05). A statistically significant difference was noted in the increase of higher order aberrations after LASIK between groups (t=−2.050, P=0.045). Conclusion: LASIK with conventional ablation and topography-guided CATz ablation resulted in the same BSCVA (best spectacle-corrected visual acuity) 3 month after LASIK. Higher order aberrations were increased, but the increase of higher order aberrations after customized ablation treatment was less than that after conventional ablation.
doi:10.1631/jzus.2007.B0177
PMCID: PMC1810384  PMID: 17323429
Myopic LASIK (laser in situ keratomileusis); Higher order aberrations; Customized ablation
23.  Color light-emitting diode reflection topography: validation of keratometric repeatability in a large sample of wide cylindrical-range corneas 
Purpose
To investigate repeatability of steep and flat keratometry measurements, as well as astigmatism axis in cohorts with normal range and regular astigmatic such as: eyes following laser-assisted in situ keratomileusis (LASIK) and normal population, as well as cohorts of high and irregular astigmatism such as keratoconic eyes, and keratoconic eyes following corneal collagen cross-linking, employing a novel corneal reflection topography device.
Methods
Steep and flat keratometry and astigmatism axis measurement repeatability was investigated employing a novel multicolored-spot reflection topographer (Cassini) in four study groups, namely a post myopic LASIK-treated Group A, a keratoconus Group B, a post-CXL keratoconus Group C, and a control Group D of routine healthy patients. Three separate, maps were obtained employing the Cassini, enabling investigation of the intra-individual repeatability by standard deviation. Additionally we investigated in all groups,the Klyce surface irregularity indices for keratoconus, the SAI (surface asymmetry index) and the SRI (surface regularity index).
Results
Flat keratometry repeatability was 0.74±0.89 (0.03 to 5.26) diopters (D) in the LASIK Group A, 0.88±1.45 (range minimum to maximum, 0.00 to 7.84) D in the keratoconic Group B, and 0.71±0.94 (0.02 to 6.23) D in the cross-linked Group C. The control Group D had flat keratometry repeatability 0.36±0.46 (0.00 to 2.71) D. Steep keratometry repeatability was 0.64±0.82 (0.01 to 4.81) D in the LASIK Group A, 0.89±1.22 (0.02 to 7.85) D in the keratoconic Group B, and 0.93±1.12 (0.04 to 5.93) D in the cross-linked Group C. The control Group D had steep keratometry repeatability 0.41±0.50 (0.00 to 3.51) D. Axis repeatability was 3.45±1.62° (0.38 to 7.78°) for the LASIK Group A, 4.12±3.17° (0.02 to 12.13°) for the keratoconic Group B, and 3.20±1.99° (0.17 to 8.61°) for the cross-linked Group C. The control Group D had axis repeatability 2.16±1.39° (0.05 to 5.86°). The SAI index measurement repeatability was 0.33±0.40 (0.01 to 2.31) in the post-LASIK Group A, 0.39±0.75 (0.00 to 7.15) in the keratoconic Group B, and 0.43±0.56 (0.05 to 3.50) in the keratoconus post-CXL Group C. The control group had SAI measurement repeatability of 0.26±0.30 (0.00 to 2.39). The SRI index repeatability was 0.22±0.17 (0.01 to 0.96) for post-LASIK Group A, 0.20±0.18 (0.00 to 1.07) in keratoconic Group B, and 0.13±0.09 (0.00 to 0.45) in the keratoconus post-CXL Group C. The control Group D had SRI measurement repeatability of 0.23±0.16 (0.00 to 0.75).
Conclusion
This novel corneal topography device appears to offer very high specificity in estimating corneal keratometry and specific corneal irregularity indices, even in topographically challenging corneas such as LASIK treated, keratoconic, and cross-linked.
doi:10.2147/OPTH.S68371
PMCID: PMC4332260  PMID: 25709385
LED topography; point-source topography; VU topographer; axis of astigmatism; Cassini topographer; steep meridian; surface regularity index; surface asymmetry index; form factor
24.  Aspheric photorefractive keratectomy for myopia and myopic astigmatism with the SCHWIND AMARIS laser: 2 years postoperative outcomes 
Journal of Optometry  2012;6(1):9-17.
Purpose
To evaluate mid-term refractive outcomes and higher order aberrations of aspheric PRK for low, moderate and high myopia and myopic astigmatism with the AMARIS excimer laser system (SCHWIND eye-tech-solutions GmbH, Kleinostheim, Germany).
Methods
This prospective longitudinal study evaluated 80 eyes of 40 subjects who underwent aspheric PRK. Manifest refractive spherical equivalent (MRSE) of up to −10.00 diopters (D) at the spectacle plane with cylinder up to 3.25 was treated. Refractive outcomes and corneal wavefront data (6 mm pupil to the 7th Zernike order) were evaluated out to 2 years postoperatively. Statistical significance was indicated by P < 0.05.
Results
The mean manifest spherical equivalent refraction (MRSE) was −4.77 ± 2.45 (range, −10.00 D to −0.75 D) preoperatively and −0.12 ± 0.35 D (range, −1.87 D to +0.75 D) postoperatively (P < 0.0001). Postoperatively, 91% (73/80) of eyes had an MRSE within ±0.50 D of the attempted. No eyes lost one or more lines of corrected distance visual acuity (CDVA) and CDVA increased by one or more lines in 26% (21/80) of eyes. Corneal trefoil and corneal higher order aberration root mean square did not statistically change postoperatively compared to preoperatively (P > 0.05, both cases). There was a statistical increase in postoperative coma (+0.12 μm) and spherical aberration (+0.14 μm) compared to preoperatively (P < 0.001, both cases).
Conclusion
Aspheric PRK provides excellent visual and refractive outcomes with induction in individual corneal aberrations but not overall corneal aberrations.
doi:10.1016/j.optom.2012.04.001
PMCID: PMC3880509
Aberrations; Aspheric; PRK; Myopia; Astigmatism; Aberraciones; Asférico; PRK; Miopía; Astigmatismo
25.  Effects of advanced surface ablations and intralase femtosecond LASIK on higher order aberrations and visual acuity outcome 
Saudi Journal of Ophthalmology  2011;25(3):275-280.
Background/aims
To study the changes in wavefront (ocular) and corneal higher order aberrations (HOAs) and visual acuity (VA) outcome following wavefront-guided advanced surface ablation (ASA) techniques and intralase femtosecond LASIK (iLASIK) in myopia treatment.
Methods
Ocular aberration and corneal topography of 240 eyes in the ASA techniques (this was equally divided into a flap-on group where the epithelial flap was preserved and reapplied to the photoablated stromal bed and a flap-off group when the epithelial flap was discarded during the procedure), and 138 eyes in the iLASIK group were obtained before and 3 months following treatment. The correlation of aberrations with best spectacle-corrected visual acuity was analyzed.
Results
At 3 months, there was statistically significant (P < 0.001) surgically induced increase in spherical aberration (SA) in each of the techniques for both ocular and corneal analysis. iLASIK induced significantly less ocular and corneal HOAs (P < 0.001). The mean manifest refractive spherical equivalent was closer to attempted correction compared to other groups (P < 0.001). Eighty-three eyes (70%) of flap-on, 80 (67%) flap-off and 94 eyes (68%) in the iLASIK group achieved 20/20 uncorrected VA. Fifteen eyes (11%) accomplished 20/12.5 or better in iLASIK compared to 4 (3%) for flap-on and 7 (6%) for flap-off ASA group. Only the flap-off treatment showed a consistent correlation between the corrected aberrations and visual performance.
Conclusion
At 3 months, all procedures resulted in a significant increase in HOAs and SA. All had comparable 20/20 VA and 11% of iLASIK patients achieved 20/12.5 or better level.
doi:10.1016/j.sjopt.2011.04.003
PMCID: PMC3729522  PMID: 23960936
Advanced corneal surface ablation; iLASIK; Higher order aberrations; Visual acuity; Excimer laser; LASIK; Femtosecond

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