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1.  Trends and Disparities in Antiretroviral Therapy Initiation and Virologic Suppression Among Newly Treatment-Eligible HIV-Infected Individuals in North America, 2001–2009 
Hanna, David B. | Buchacz, Kate | Gebo, Kelly A. | Hessol, Nancy A. | Horberg, Michael A. | Jacobson, Lisa P. | Kirk, Gregory D. | Kitahata, Mari M. | Korthuis, P. Todd | Moore, Richard D. | Napravnik, Sonia | Patel, Pragna | Silverberg, Michael J. | Sterling, Timothy R. | Willig, James H. | Lau, Bryan | Althoff, Keri N. | Crane, Heidi M. | Collier, Ann C. | Samji, Hasina | Thorne, Jennifer E. | Gill, M. John | Klein, Marina B. | Martin, Jeffrey N. | Rodriguez, Benigno | Rourke, Sean B. | Gange, Stephen J. | Benson, A. | Bosch, Ronald J. | Collier, Ann C. | Boswell, Stephen | Grasso, Chris | Mayer, Ken | Hogg, Robert S. | Harrigan, Richard | Montaner, Julio | Cescon, Angela | Brooks, John T. | Buchacz, Kate | Gebo, Kelly A. | Moore, Richard D. | Rodriguez, Benigno | Horberg, Michael A. | Silverberg, Michael J. | Thorne, Jennifer E. | Goedert, James J. | Jacobson, Lisa P. | Klein, Marina B. | Rourke, Sean B. | Burchell, Ann | Rachlis, Anita R. | Hunter-Mellado, Robert F. | Mayor, Angel M. | Gill, M. John | Deeks, Steven G. | Martin, Jeffrey N. | Saag, Michael S. | Mugavero, Michael J. | Willig, James | Eron, Joseph J. | Napravnik, Sonia | Kitahata, Mari M. | Crane, Heidi M. | Justice, Amy C. | Dubrow, Robert | Fiellin, David | Sterling, Timothy R. | Haas, David | Bebawy, Sally | Turner, Megan | Gange, Stephen J. | Anastos, Kathryn | Moore, Richard D. | Saag, Michael S. | Gange, Stephen J. | Kitahata, Mari M. | McKaig, Rosemary G. | Justice, Amy C. | Freeman, Aimee M. | Moore, Richard D. | Freeman, Aimee M. | Lent, Carol | Platt, Aaron | Kitahata, Mari M. | Van Rompaey, Stephen E. | Crane, Heidi M. | Webster, Eric | Morton, Liz | Simon, Brenda | Gange, Stephen J. | Abraham, Alison G. | Lau, Bryan | Althoff, Keri N. | Zhang, Jinbing | Jing, Jerry | Golub, Elizabeth | Modur, Shari | Hanna, David B. | Rebeiro, Peter | Wong, Cherise | Mendes, Adell
In the last decade, timely initiation of antiretroviral therapy and resulting virologic suppression have greatly improved in North America concurrent with the development of better tolerated and more potent regimens, but significant barriers to treatment uptake remain.
Background. Since the mid-1990s, effective antiretroviral therapy (ART) regimens have improved in potency, tolerability, ease of use, and class diversity. We sought to examine trends in treatment initiation and resulting human immunodeficiency virus (HIV) virologic suppression in North America between 2001 and 2009, and demographic and geographic disparities in these outcomes.
Methods. We analyzed data on HIV-infected individuals newly clinically eligible for ART (ie, first reported CD4+ count <350 cells/µL or AIDS-defining illness, based on treatment guidelines during the study period) from 17 North American AIDS Cohort Collaboration on Research and Design cohorts. Outcomes included timely ART initiation (within 6 months of eligibility) and virologic suppression (≤500 copies/mL, within 1 year). We examined time trends and considered differences by geographic location, age, sex, transmission risk, race/ethnicity, CD4+ count, and viral load, and documented psychosocial barriers to ART initiation, including non–injection drug abuse, alcohol abuse, and mental illness.
Results. Among 10 692 HIV-infected individuals, the cumulative incidence of 6-month ART initiation increased from 51% in 2001 to 72% in 2009 (Ptrend < .001). The cumulative incidence of 1-year virologic suppression increased from 55% to 81%, and among ART initiators, from 84% to 93% (both Ptrend < .001). A greater number of psychosocial barriers were associated with decreased ART initiation, but not virologic suppression once ART was initiated. We found significant heterogeneity by state or province of residence (P < .001).
Conclusions. In the last decade, timely ART initiation and virologic suppression have greatly improved in North America concurrent with the development of better-tolerated and more potent regimens, but significant barriers to treatment uptake remain, both at the individual level and systemwide.
doi:10.1093/cid/cit003
PMCID: PMC3657490  PMID: 23315317
antiretroviral therapy; healthcare disparities; HIV; time factors; viral load
2.  Retention Among North American HIV–infected Persons in Clinical Care, 2000–2008 
Background
Retention in care is key to improving HIV outcomes. Our goal was to describe “churn” in patterns of entry, exit, and retention in HIV care in the US and Canada.
Methods
Adults contributing ≥1 CD4 count or HIV-1 RNA (HIV-lab) from 2000–2008 in North American Cohort Collaboration on Research and Design (NA-ACCORD) clinical cohorts were included. Incomplete retention was defined as lack of 2 HIV-labs (≥90 days apart) within 12 months, summarized by calendar year. We used beta-binomial regression models to estimate adjusted odds ratios (OR) and 95% confidence intervals (CI) of factors associated with incomplete retention.
Results
Among 61,438 participants, 15,360 (25%) with incomplete retention significantly differed in univariate analyses (p<0.001) from 46,078 (75%) consistently retained by age, race/ethnicity, HIV risk, CD4, ART use, and country of care (US vs. Canada). From 2000–2004, females (OR=0.82, CI:0.70–0.95), older individuals (OR=0.78, CI:0.74–0.83 per 10 years), and ART users (OR= 0.61, CI:0.54–0.68 vs all others) were less likely to have incomplete retention, while black individuals (OR=1.31, CI:1.16–1.49, vs. white), those with injection drug use (IDU) HIV risk (OR=1.68, CI:1.49–1.89, vs. non-IDU) and those in care longer (OR=1.09, CI:1.07–1.11 per year) were more likely to have incomplete retention. Results from 2005–2008 were similar.
Discussion
From 2000 to 2008, 75% of the NA-ACCORD population was consistently retained in care with 25% experiencing some change in status, or churn. In addition to the programmatic and policy implications, our findings identify patient groups who may benefit from focused retention efforts.
doi:10.1097/QAI.0b013e31827f578a
PMCID: PMC3661708  PMID: 23242158
retention; churn; HIV clinical care; North America; HRSA HAB; National HIV/AIDS Strategy
3.  The Role of Gender in Juvenile Idiopathic Arthritis-Associated Uveitis 
Journal of Ophthalmology  2014;2014:461078.
Uveitis is a common complication of juvenile idiopathic arthritis (JIA) affecting up to 30% of patients with JIA. Although the typical bilateral chronic anterior uveitis associated with the persistent and extended oligoarticular and polyarticular, rheumatoid factor negative variants of JIA occurs predominantly in girls, boys may be more commonly affected in the HLA-B27 positive, enthesitis variant of JIA. While female gender has been associated with the development of the chronic anterior uveitis in children with JIA, the clinical course of JIA-associated uveitis may be worse in boys than in girls. The purpose of this paper is to review the available published literature to determine the role of gender in the clinical presentation and outcomes of patients with JIA-associated uveitis.
doi:10.1155/2014/461078
PMCID: PMC3950556  PMID: 24701346
4.  Risk Factors for Loss of Visual Acuity among Patients with Uveitis Associated With Juvenile Idiopathic Arthritis: The SITE Study 
Ophthalmology  2012;120(1):186-192.
Purpose
To describe the incidence of and risk factors for visual acuity (VA) loss and ocular complications in patients with juvenile idiopathic arthritis (JIA)-associated uveitis.
Design
Multicenter retrospective cohort study.
Participants
327 patients (596 affected eyes) with JIA-associated uveitis managed at five tertiary uveitis clinics in the United States.
Methods
Participants were identified from the Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study. Demographic and clinical characteristics were obtained for every eye of every patient at every visit via medical record review by trained expert reviewers.
Main Outcome Measures
Loss of VA to 20/50 or to 20/200 or worse thresholds and the development of ocular complications.
Results
At presentation, 240 (40.3%) eyes had a VA of 20/50 or worse; 144 (24.2%) had a VA of 20/200 or worse; 359 (60.2%) had at least one ocular complication. The incidences of VA loss to the 20/50 or worse and 20/200 or worse thresholds were 0.18 and 0.09 per eye-year (EY), respectively; the incidence of developing at least one new ocular complication over follow-up was 0.15/EY (95% confidence interval [CI]: 0.13/EY, 0.17/EY). However, among eyes with uveitis that had no complications at presentation, the rate of developing at least one ocular complication during follow up was lower (0.04/EY, 95% CI: 0.02, 0.06). Posterior synechiae, active uveitis, and prior intraocular surgery were statistically significantly associated with VA to the 20/50 or worse and 20/200 or worse thresholds, both at presentation and during follow-up. Increasing (time-updated) anterior chamber cell grade was associated with increased rates of visual loss in a dose-dependent fashion. Use of immunosuppressive drugs was associated with a reduced the risk of visual loss, particularly for the 20/50 or worse outcome (hazard ratio = 0.40, 95% CI: 0.21, 0.75, P<0.01).
Conclusions
Ocular complications and vision loss were common in our cohort. Increasing uveitis activity was associated with increased risk of vision loss and use of immunosuppressive drugs was associated with reduced risk of vision loss suggesting that control of inflammation and use of immunosuppression may be critical aspects in improving the outcomes of patients with JIA-related uveitis.
doi:10.1016/j.ophtha.2012.07.052
PMCID: PMC3536914  PMID: 23062650
5.  Spectral domain optical coherence tomography findings in acute syphilitic posterior placoid chorioretinitis 
Background
We describe the spectral domain optical coherence tomography (SD-OCT) findings in three patients with acute syphilitic posterior placoid chorioretinitis (ASPPC). The SD-OCT images demonstrate the pathologic changes in ASPPC with a high level of anatomic detail and may provide information about the pathophysiology of the disease.
Findings
We report a series of three consecutive patients seen at the Wilmer Eye Institute in 2012 and 2013 who presented with clinical and laboratory findings consistent with a diagnosis of unilateral ASPPC. Two of the three patients had HIV co-infection with good immune recovery. SD-OCT images from their initial (pre-treatment) presentation demonstrated thickening and hyperreflective nodularity of the choroid-retinal pigment epithelium (RPE) complex, with focal disruption of the overlying photoreceptor inner segment-outer segment junction in the areas corresponding to the retinal lesions seen on clinical examination. These changes improved with intravenous antibiotic treatment over a 3-month period of follow-up.
Conclusions
SD-OCT imaging in ASPPC demonstrates reversible, focal thickening, and nodularity of the RPE with disruption of the overlying photoreceptor inner segment-outer segment junction. We believe that these SD-OCT images support the concept that ASPPC involves an inflammatory process at the level of the choroid-RPE with resultant structural and functional changes in the retinal photoreceptors. Further study with OCT imaging may be helpful in better understanding this disease.
doi:10.1186/1869-5760-4-2
PMCID: PMC3917537  PMID: 24468306
Syphilis; Chorioretinis; Optical coherence tomography; Retinal pigment epithelium; Photoreceptor
6.  Association between U.S. State AIDS Drug Assistance Program (ADAP) Features and HIV Antiretroviral Therapy Initiation, 2001–2009 
PLoS ONE  2013;8(11):e78952.
Background
U.S. state AIDS Drug Assistance Programs (ADAPs) are federally funded to provide antiretroviral therapy (ART) as the payer of last resort to eligible persons with HIV infection. States differ regarding their financial contributions to and ways of implementing these programs, and it remains unclear how this interstate variability affects HIV treatment outcomes.
Methods
We analyzed data from HIV-infected individuals who were clinically-eligible for ART between 2001 and 2009 (i.e., a first reported CD4+ <350 cells/uL or AIDS-defining illness) from 14 U.S. cohorts of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD). Using propensity score matching and Cox regression, we assessed ART initiation (within 6 months following eligibility) and virologic suppression (within 1 year) based on differences in two state ADAP features: the amount of state funding in annual ADAP budgets and the implementation of waiting lists. We performed an a priori subgroup analysis in persons with a history of injection drug use (IDU).
Results
Among 8,874 persons, 56% initiated ART within six months following eligibility. Persons living in states with no additional state contribution to the ADAP budget initiated ART on a less timely basis (hazard ratio [HR] 0.73, 95% CI 0.60–0.88). Living in a state with an ADAP waiting list was not associated with less timely initiation (HR 1.12, 95% CI 0.87–1.45). Neither additional state contributions nor waiting lists were significantly associated with virologic suppression. Persons with an IDU history initiated ART on a less timely basis (HR 0.67, 95% CI 0.47–0.95).
Conclusions
We found that living in states that did not contribute additionally to the ADAP budget was associated with delayed ART initiation when treatment was clinically indicated. Given the changing healthcare environment, continued assessment of the role of ADAPs and their features that facilitate prompt treatment is needed.
doi:10.1371/journal.pone.0078952
PMCID: PMC3832515  PMID: 24260137
7.  Post-operative outcomes following fluocinolone acetonide implant surgery in patients with Birdshot chorioretinitis and other types of posterior and panuveitis. 
Retina (Philadelphia, Pa.)  2013;33(8):10.1097/IAE.0b013e31828396cf.
Purpose
To evaluate outcomes following placement of fluocinolone acetonide (FA) implants in eyes with Birdshot chorioretinitis (BSCR) and to compare these outcomes with eyes with posterior and panuveitis.
Methods
This is a retrospective cohort study of 48 eyes from patients with posterior and panuveitis treated with FA implants from 2006 through 2010. Outcome measures include visual acuity, intraocular pressure (IOP), need for glaucoma surgery, postoperative complications, and control of inflammation.
Results
All eyes treated with FA implants achieved improved control of inflammation and decreased reliance on adjunctive therapy. BSCR eyes had a statistically significant increase in IOP in the first four months after FA implantation (p = 0.04) as compared to baseline IOP. A higher percentage of eyes with BSCR required glaucoma surgery and after a shorter time period following FA implantation than did eyes with other forms of posterior and panuveitis (0.42/EY versus 0.11/EY; median time to glaucoma surgery: 15.5 vs. 31.5 months respectively, hazard ratio = 3.4, 95% CI 1.0-10.8, p = 0.04).
Conclusions
Although the FA implant is effective in controlling inflammation and reducing the need for systemic immunosuppressive therapy, eyes of patients with BSCR tended to have a more robust IOP response to the FA implant than eyes with other types of posterior and panuveitis.
doi:10.1097/IAE.0b013e31828396cf
PMCID: PMC3828657  PMID: 23549097
Birdshot chorioretinitis; fluocinolone acetonide implant; posterior uveitis
8.  Risk of Hypotony in Non-infectious Uveitis 
Ophthalmology  2012;119(11):2377-2385.
Objective
To describe the risk and risk factors for hypotony in a non-infectious uveitis cohort.
Design
Retrospective cohort study.
Participants
Patients with non-infectious uveitis seen between 1979-2007 at four academic ocular inflammation specialty clinics.
Method
Data were collected by trained, certified, expert reviewers from medical records.
Main Outcome Measures
Hypotony (<5mmHg) and low intraocular pressure (<8mmHg), each sustained for ≥2 visits spanning at least 30 days.
Results
During follow-up, 126/6785 (1.86%) developed hypotony at the rate of 0.61%(95% Confidence Interval (CI) 0.50, 0.75%)/eye-year. Cataract surgery was associated with a 7.5-fold risk (adjusted hazard ratio (aHR = 7.51, 95% CI 3.97,14.23) of incident hypotony. Phacoemulsification, the type of cataract surgery associated with the least hypotony risk still was associated with nearly five-fold higher hypotony incidence (aHR =4.87, 95% CI 2.25, 10.55). Increased risk was observed in children (aHR =2.92, 95% CI 1.20, 7.10) with respect to young adults, and duration of uveitis of >5 years (aHR =3.08, 95% CI 1.30, 7.31) with respect to uveitis of <6 month duration. ≥3+ vitreous cells, band keratopathy, exudative retinal detachment, posterior synechia and history of pars plana vitrectomy also were associated with greater hypotony incidence. With respect to anterior uveitis, intermediate uveitis (aHR = 0.17, 95% CI 0.05,0.56) and posterior uveitis (aHR =0.11, 95% CI 0.03,0.45) were associated with lower hypotony risk, whereas panuveitis (aHR=1.25, 95% CI 0.67, 2.35) was similar. Approximately five-sixths (84.1%) of eyes presenting with hypotony had a visual acuity of 20/200 or worse (aOR for visual acuity 20/200 or worse=13.85, 95% CI 7.23, 26.53). Risk factors for prevalent hypotony were similar.
Conclusions
The risk of hypotony is low among eyes with non-infectious uveitis, but is more frequently observed in cases with anterior segment inflammation. Signs of present or past inflammation were associated with higher risk, suggesting excellent inflammatory control may reduce the risk of hypotony. Prior ocular surgery also was associated with higher risk; cataract surgery in particular was associated with much higher risk of hypotony. Lower risk of hypotony with phacoemulsification than alternative cataract surgery approaches suggests the phacoemulsification approach is preferable.
doi:10.1016/j.ophtha.2012.05.032
PMCID: PMC3475753  PMID: 22796306
9.  Methotrexate for Ocular Inflammatory Diseases 
Ophthalmology  2009;116(11):2188-98.e1.
Purpose
To evaluate the outcome of treatment with methotrexate for noninfectious ocular inflammation.
Design
Retrospective cohort study.
Participants
Patients with noninfectious ocular inflammation managed at 4 tertiary ocular inflammation clinics in the United States observed to add methotrexate as a single, noncorticosteroid immunosuppressive agent to their treatment regimen, between 1979 and 2007, inclusive.
Methods
Participants were identified from the Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study. Demographic and clinical characteristics, including dosage, route of administration of methotrexate, and main outcome measures, were obtained for every eye of every patient at every visit via medical record review by trained expert reviewers.
Main Outcome Measures
Control of inflammation, corticosteroid-sparing effects, and incidence of and reason for discontinuation of therapy.
Results
Among 384 patients (639 eyes) observed from the point of addition of methotrexate to an anti-inflammatory regimen, 32.8%, 9.9%, 21.4%, 14.6%, 15.1%, and 6.3%, respectively, had anterior uveitis, intermediate uveitis, posterior or panuveitis, scleritis, ocular mucous membrane pemphigoid, and other forms of ocular inflammation. In these groups, complete suppression of inflammation sustained for ≥28 days was achieved within 6 months in 55.6%, 47.4%, 38.6%, 56.4%, 39.5%, and 76.7%, respectively. Corticosteroid-sparing success (sustained suppression of inflammation with prednisone ≤10 mg/d) was achieved within 6 months among 46.1%, 41.3%, 20.7%, 37.3%, 36.5%, and 50.9%, respectively. Overall, success within 12 months was 66% and 58.4% for sustained control and corticosteroid sparing ≤10 mg), respectively. Methotrexate was discontinued within 1 year by 42% of patients. It was discontinued owing to ineffectiveness in 50 patients (13%); 60 patients (16%) discontinued because of side effects, which typically were reversible with dose reduction or discontinuation. Remission was seen in 43 patients, with 7.7% remitting within 1 year of treatment.
Conclusions
Our data suggest that adding methotrexate to an anti-inflammatory regimen not involving other noncorticosteroid immunosuppressive drugs is moderately effective for management of inflammatory activity and for achieving corticosteroid-sparing objectives, although many months may be required for therapeutic success. Methotrexate was well tolerated by most patients, and seems to convey little risk of serious side effects during treatment.
Financial Disclosure(s)
The authors have no proprietary or commercial interests in any of the materials discussed in this article.
doi:10.1016/j.ophtha.2009.04.020
PMCID: PMC3785935  PMID: 19748676
10.  Risk of corticosteroid-induced hyperglycemia requiring medical therapy among patients with inflammatory eye diseases 
Ophthalmology  2012;119(8):1569-1574.
Objective
To identify the incidence and risk factors for corticosteroid-induced hyperglycemia requiring medical therapy among patients with inflammatory eye diseases.
Design
Retrospective cohort study.
Participants
Patients with ocular inflammation followed at five United States tertiary centers who initially were neither diabetic nor taking hypoglycemic medications.
Methods
Eligible patients who used oral corticosteroids during follow-up were identified and followed longitudinally for initiation of hypoglycemic medication over one year after beginning corticosteroids. The remaining eligible patients were followed for one year after their initial visit. Survival analysis was used to calculate the risk of hyperglycemia requiring medical therapy, and to identify potential risk factors.
Main Outcome Measures
Initiation of hypoglycemic medications.
Results
Among 2,073 non-diabetic patients treated with oral corticosteroids, 25 (1.21%) initiated hypoglycemic therapy compared with 5 (0.19%) of 2,666 patients not treated with oral corticosteroids (relative risk (RR) = 4.39, 95% Confidence Interval (CI) = 1.68 – 11.5). Relative risk tended to be higher in association with higher initial doses (For initial doses <40 mg of prednisone/day, RR=3.23, 95% CI: 1.08–9.64; for initial prednisone dose ≥40 mg/day, RR=5.51, 95% CI: 2.01–15.1). Other risk factors for the initiation of hypoglycemic therapy included older age (RR (per each additional 10 years) = 1.46, 95% CI = 1.15 – 1.85, p = 0.002) and African-American race (RR = 2.94, 95% CI = 1.34 – 6.43, p = 0.007).
Conclusions
These results suggest that the absolute risk of corticosteroid-induced hyperglycemia that is detected and treated with hypoglycemic therapy in the tertiary ocular inflammation setting is low (an excess cumulative risk on the order of 1% within one year), although on a relative scale it is approximately 4.4-fold higher than in patients not treated with oral corticosteroids. Higher age and African-American race also were risk factors. Physicians who use systemic corticosteroids for ocular inflammatory diseases should be aware of this risk, and should consider surveillance for hyperglycemia among high-risk patients. However, given the low absolute risk, routine laboratory monitoring or referral for monitoring may not be necessary for low risk patients.
doi:10.1016/j.ophtha.2012.01.043
PMCID: PMC3394895  PMID: 22484116
11.  Incidence of Cytomegalovirus Retinitis in the Era of Highly Active Antiretroviral Therapy 
American Journal of Ophthalmology  2012;153(6):1016-1024.e5.
Purpose
To estimate the incidence of cytomegalovirus (CMV) retinitis in the era of highly active antiretroviral therapy (HAART) and to characterize the factors associated with increased risk of CMV retinitis.
Design
Prospective cohort study
Methods
1600 participants with acquired immune deficiency syndrome (AIDS) but without CMV retinitis at enrollment who completed at least one follow-up visit in the Longitudinal Study of the Ocular Complications of AIDS (LSOCA) were seen every 6 months to obtain disease and treatment history, ophthalmic examination, and laboratory testing. Incidence of CMV retinitis and risk factors for incident CMV retinitis were assessed.
Results
The incidence rate of CMV retinitis in individuals with AIDS was 0.36/100 person years (PY) based upon 29 incident cases during 8,134 person-years of follow-up. The rate was higher for those with a CD4+ T cell count at the immediately prior visit below 50 cells/μL (3.89/100 PY, p < 0.01), whereas only one individual with a CD4+ T cell count of 50–99 cells/μL and two individuals with a CD4+ T cell count > 100 cells/μL developed CMV retinitis. Having a CD4+ T cell count below 50 cells/μL at the clinical visit prior to CMV retinitis evaluation was the single most important risk factor (HR: 136, 95% CI: 30 to 605, p < 0.0001) for developing retinitis.
Conclusions
Patients with AIDS, especially those with severely compromised immune systems, remain at risk for developing CMV retinitis in the HAART era, although the incidence rate is reduced from that observed in the pre-HAART era.
doi:10.1016/j.ajo.2011.11.014
PMCID: PMC3358595  PMID: 22310076
12.  High-Dose Intravenous Corticosteroids for Ocular Inflammatory Diseases 
Purpose
To evaluate the effectiveness and risk of complications of high-dose intravenous pulsed corticosteroids for non-infectious ocular inflammatory diseases.
Methods
Retrospective cohort study. One hundred four eyes of seventy patients who received high-dose intravenous corticosteroids for treatment of active ocular inflammation were identified from five centers. The main outcome measures were control of inflammation and occurrence of ocular or systemic complications within one month after treatment.
Results
Within ≤1 month of starting treatment, 57% of eyes achieved complete control of inflammation (95% confidence interval (CI): 33-83%), improving to 82% when near-complete control was included (95% CI: 61-96%). Most eyes (85%; 95% CI: 70-95%) gained clinically significant improvement in anterior chamber inflammation. One patient developed a colon perforation during treatment. No other major complications were recorded.
Conclusions
Treatment of ocular inflammation with high-dose intravenous corticosteroids resulted in substantial clinical improvement for most cases within one month. Complications of therapy were infrequent.
doi:10.3109/09273948.2011.646382
PMCID: PMC3306126  PMID: 22409561
Corticosteroids; Inflammation; Intravenous; Non-infectious; Uveitis
13.  RETINAL VESSEL CALIBER AMONG PEOPLE WITH AIDS: RELATIONSHIPS WITH DISEASE-ASSOCIATED FACTORS AND MORTALITY 
American Journal of Ophthalmology  2011;153(3):434-444.e1.
Purpose
To evaluate relationships between retinal vessel caliber, AIDS-related factors, and mortality.
Design
Longitudinal, observational, cohort study.
Methods
We evaluated data for participants without ocular opportunistic infections at initial examination (baseline) in the Longitudinal Studies of the Ocular Complications of AIDS (1998–2008). Semi-automated evaluation of fundus photographs (1 eye/participant) determined central retinal artery equivalent (CRAE), central retinal vein equivalent (CRVE), and arteriole:venule ratio (AVR) at baseline. Multiple linear regression models, using forward selection, identified independent relationships between indices and various host- and disease-related variables.
Results
Included were 1250 participants. Mean follow-up for determination of mortality was 6.1 years. Smaller CRAE was related to increased age (p<0.001) and hypertension (p<0.001); larger CRAE was related to lower hematocrit (p=0.002). Larger CRAE and CRVE were associated with black race (p<0.001). Larger CRVE was related to smoking (p=0.004); smaller CRVE was related to age (p<0.001) and higher mean corpuscular volume (p=0.001). We observed the following relationships with AIDS-associated factors: smaller CRAE and larger CRVE with history of highly active antiretroviral therapy (HAART; p<0.001); and larger CRAE with lower CD4+ T-lymphocyte count (p=0.04). We did not identify independent relationships with HIV RNA blood levels. There was a 12% (95% CI, 2–21%) increase in mortality risk per quartile of decreasing AVR (p=0.02).
Conclusions
Variations in retinal vascular caliber are associated with AIDS-specific factors, and are markers for increased mortality risk. Relationships are consistent with the hypothesis that the vasculature is altered by known atherogenic effects of chronic HAART or the prolonged inflammatory state associated with AIDS.
doi:10.1016/j.ajo.2011.08.028
PMCID: PMC3289046  PMID: 22019225
14.  U.S. Trends in Antiretroviral Therapy Use, HIV RNA Plasma Viral Loads, and CD4 T-Lymphocyte Cell Counts Among HIV-Infected Persons, 2000 to 2008 
Annals of internal medicine  2012;157(5):325-335.
Background
The U.S. National HIV/AIDS Strategy targets for 2015 include increasing access to care and improving health outcomes for persons living with HIV in the United States (PLWH-US).
Objective
To demonstrate the utility of the NA-ACCORD (North American AIDS Cohort Collaboration on Research and Design) for monitoring trends in the HIV epidemic in the United States and to present trends in HIV treatment and related health outcomes.
Design
Trends from annual cross-sectional analyses comparing patients from pooled, multicenter, prospective, clinical HIV cohort studies with PLWH-US, as reported to national surveillance systems in 40 states.
Setting
U.S. HIV outpatient clinics.
Patients
HIV-infected adults with 1 or more HIV RNA plasma viral load (HIV VL) or CD4 T-lymphocyte (CD4) cell count measured in any calendar year from 1 January 2000 to 31 December 2008.
Measurements
Annual rates of antiretroviral therapy use, HIV VL, and CD4 cell count at death.
Results
45 529 HIV-infected persons received care in an NA-ACCORD–participating U.S. clinical cohort from 2000 to 2008. In 2008, the 26 030 NA-ACCORD participants in care and the 655 966 PLWH-US had qualitatively similar demographic characteristics. From 2000 to 2008, the proportion of participants prescribed highly active antiretroviral therapy increased by 9 percentage points to 83% (P < 0.001), whereas the proportion with suppressed HIV VL (≤2.7 log10 copies/mL) increased by 26 percentage points to 72% (P < 0.001). Median CD4 cell count at death more than tripled to 0.209 × 109 cells/L (P < 0.001).
Limitation
The usual limitations of observational data apply.
Conclusion
The NA-ACCORD is the largest cohort of HIV-infected adults in clinical care in the United States that is demographically similar to PLWH-US in 2008. From 2000 to 2008, increases were observed in the percentage of prescribed HAART, the percentage who achieved a suppressed HIV VL, and the median CD4 cell count at death.
Primary Funding Source
National Institutes of Health, Centers for Disease Control and Prevention, Canadian Institutes of Health Research, Canadian HIV Trials Network, and the government of British Columbia, Canada.
doi:10.7326/0003-4819-157-5-201209040-00005
PMCID: PMC3534765  PMID: 22944874
15.  Necrotizing scleritis as a complication of cosmetic eye whitening procedure 
Background
We report necrotizing scleritis as a serious complication of a cosmetic eye whitening procedure that involves the use of intraoperative and postoperative topical mitomycin C.
Findings
This is a single case report. A 59-year-old Caucasian male with a history of blepharitis status post uncomplicated LASIK refractive surgery reported chronic conjunctival hyperemia for 15 years prior to undergoing a cosmetic eye whitening procedure. He presented to our clinic 12 months after the cosmetic eye whitening procedure with progressive bilateral necrotizing scleritis and scleral calcification.
Conclusions
Chronic conjunctival hyperemia may prompt patients to seek surgical correction with cosmetic eye whitening procedures. However, conjunctival hyperemia secondary to tear deficiency and evaporative dry eye may predispose to poor wound healing. Serious complications including necrotizing scleritis may result from cosmetic eye whitening procedures and the use of topical mitomycin C.
doi:10.1186/1869-5760-3-39
PMCID: PMC3605078  PMID: 23514228
Necrotizing scleritis; I-BRITE; Cosmetic eye whitening; Mitomycin C
16.  Identifying a Clinically Meaningful Threshold for Change in Uveitic Macular Edema Evaluated by Optical Coherence Tomography 
American journal of ophthalmology  2011;152(6):1044-1052.e5.
Purpose
To identify a clinically meaningful threshold for change in retinal thickness measured by optical coherence tomography (OCT) for patients with uveitic macular edema, using correlation with change in visual acuity.
Design
Cross-sectional and longitudinal study.
Methods
128 eyes (101 individuals) with macular edema enrolled in the Multicenter Uveitis Steroid Treatment (MUST) trial. At enrollment and after six months of follow-up, retinal thickness was measured at the central subfield with time domain OCT and visual acuity was measured with logarithmic (ETDRS) visual acuity charts. Participants were classified as having macular edema if the retinal thickness was ≥260μm.
Results
A threshold for change in retinal center subfield thickness of 20% balanced the percentage of false positives and negatives for predicting greater than 10-letter change in visual acuity with sensitivity of 77% and a specificity of 75%. The results were similar for greater than 5 or 15 or greater letter changes. Those with a 20% or greater reduction in retinal thickness had a mean 11.0 letter improvement (95% CI: 7.7 to 14.3) as compared to a -0.4 letter change (95% CI: -4.1 to 3.3) in visual acuity for those without a 20% reduction (p < 0.01).
Conclusions
In addition to being above the level of measurement uncertainty, a 20% change in retinal thickness in patients with macular edema appears to be optimal for clinically important changes in visual acuity and may be considered as an outcome for clinical trials of treatments for uveitic macular edema.
doi:10.1016/j.ajo.2011.05.028
PMCID: PMC3223264  PMID: 21861971
17.  Risk of Relapse in Primary Acute Anterior Uveitis 
Ophthalmology  2011;118(10):1911-1915.
Purpose
To evaluate the risk of and risk factors for a second episode (relapse) among patients with remitted primary anterior uveitis.
Design
Retrospective cohort study.
Participants
Patients with primary anterior uveitis presenting to one of 4 academic ocular inflammation subspecialty practices achieving remission of the primary episode within 90 days of initial uveitis diagnosis.
Methods
Data were obtained by standardized chart review.
Main outcome measures
Time-to-relapse of anterior uveitis and risk factors for relapse.
Results
102 patients with a first episode of anterior uveitis were seen within 90 days of first-ever uveitis onset and followed for 165 person-years after achieving remission of the initial episode. Most patients were female (60%) and white (78%). Forty patients had a recurrence of anterior uveitis. The incidence of relapse was 24% per person-year (95% Confidence Interval [CI]: 17–33%). At 1.5 years after remission, 61% (95% CI: 48–71%) were still in remission. Younger adults had significantly higher relapse risk than middle-aged adults (hazard ratio [18–35 year-old persons vs. 35–55 year-old persons]=2.7, 95% CI: 1.3–6.0).
Conclusions
Our results suggest that many patients with remitted primary anterior uveitis presenting for tertiary uveitis care will relapse. Age in the young adult range was associated with higher risk of relapse. Given the high relapse risk, management of patients with primary anterior uveitis should include an explicit plan for detecting and managing relapses.
doi:10.1016/j.ophtha.2011.02.044
PMCID: PMC3179829  PMID: 21680024
18.  Evaluation of the United States Public Health Service guidelines for discontinuation of anti-CMV therapy after immune recovery in patients with CMV retinitis 
American journal of ophthalmology  2011;152(4):628-637.e1.
Purpose
To evaluate US Public Health Service (USPHS) guidelines for discontinuing anti-CMV therapy in patients with AIDS who have immune recovery and quiescent retinitis after initiating highly active anti-retroviral therapy (HAART).
Design
Cohort study of patients with CMV retinitis (Longitudinal Study of Ocular Complications of AIDS).
Methods
Participants had CMV retinitis and CD4+ T-cell counts of 50 cells/uL or fewer enrolled from 1998 to 2009 who demonstrated sustained immune recovery (two consecutive CD4+ T-cell counts of 100 cells/uL or more at least 6 months apart) and inactive retinitis. Participants were classified into 2 groups according to anti-CMV treatment after immune recover: (1) continued anti-CMV therapy and (2) discontinued therapy. We evaluated survival, visual acuity, and CMV retinitis activity; we employed propensity scores to adjust for confounding factors for these analyses.
Results
Of 152 participants reviewed, 71 demonstrated immune recovery; 37 of whom discontinued therapy and 34 who continued therapy. At immune recovery, participants continuing therapy tended to be older (44 vs 40 years, P=0.09), have bilateral retinitis (53% vs 32%, P=0.10), and have lower CD4+ T-cell counts (148 vs 207 cells/μL, P<0.001). There were no statistical differences in any of the clinical outcomes (death, retinitis progress, visual acuity or incidence of bilateral retinitis). Both groups lost visual acuity during follow-up, on average 1.2 letters per year (P<0.01).
Conclusion
Discontinuation of anti-CMV therapy after immune recovery did not increase the risk of poor outcomes. These results support the current guidelines for discontinuation of anti-CMV therapy after achievement of sustained immune recovery.
doi:10.1016/j.ajo.2011.04.007
PMCID: PMC3185165  PMID: 21742304
CMV retinitis; immune recovery; maintenance therapy; USPHS guidelines
19.  Randomized Comparison of Systemic Anti-inflammatory Therapy Versus Fluocinolone Acetonide Implant for Intermediate, Posterior and Panuveitis: The Multicenter Uveitis Steroid Treatment Trial 
Ophthalmology  2011;118(10):1916-1926.
Objective
To compare the relative effectiveness of systemic corticosteroids plus immunosuppression when indicated (systemic therapy) versus fluocinolone acetonide implant (implant therapy) for non-infectious intermediate, posterior or panuveitis (uveitis).
Design
Randomized controlled parallel superiority trial.
Participants
Patients with active/recently active uveitis.
Methods
Participants were randomized (allocation ratio 1:1) to systemic or implant therapy at 23 centers (three countries). Implant-assigned participants with bilateral uveitis were assigned to have each eye that warranted study treatment implanted. Treatment-outcome associations were analyzed by assigned treatment for all eyes with uveitis.
Main Outcome Measures
Masked examiners measured the primary outcome: change in best-corrected visual acuity from baseline. Secondary outcomes included patient-reported quality of life (QoL), ophthalmologist-graded uveitis activity, and local and systemic complications of uveitis or therapy. Reading Center graders and glaucoma specialists assessing ocular complications were masked. Participants, ophthalmologists, and coordinators were unmasked.
Results
Among 255 patients randomized to implant and systemic therapy (479 eyes with uveitis), evaluating changes from baseline to 24 months, the implant and systemic therapy groups respectively had +6.0 vs. +3.2 letters' improvement in visual acuity (p=0.16, 95% confidence interval on difference in improvement between groups: −1.2 to +6.7 letters, positive values favoring implant), +11.4 vs. +6.8 units' vision-related QoL improvement (p=0.043), +0.02 vs. −0.02 change in EuroQol-EQ5D health utility (p=0.060), and 12% vs. 29% had active uveitis (p=0.001). Over 24 months, implant-assigned eyes had a higher risk of cataract surgery (80%, hazard ratio (HR) = 3.3, p<0.0001), treatment for elevated intraocular pressure (61%, HR=4.2, p<0.0001), and glaucoma (17%, HR = 4.2, p=0.0008). Systemic-assigned patients had more prescription-requiring infections (0.60 vs. 0.36/person-year, p=0.034), without notable long-term consequences; systemic adverse outcomes otherwise were unusual in both groups, with minimal differences between groups.
Conclusion
In each treatment group, mean visual acuity improved over 24 months, with neither approach superior to a degree detectable with the study's power. Therefore, the specific advantages and disadvantages identified should dictate selection between the alternative treatments in consideration of individual patients' particular circumstances. Systemic therapy with aggressive use of corticosteroid-sparing immunosuppression was well-tolerated, suggesting that this approach is reasonably safe for local and systemic inflammatory disorders.
doi:10.1016/j.ophtha.2011.07.027
PMCID: PMC3191365  PMID: 21840602
20.  Risk Factors for Tuberculosis After Highly Active Antiretroviral Therapy Initiation in the United States and Canada: Implications for Tuberculosis Screening 
The Journal of Infectious Diseases  2011;204(6):893-901.
Background. Screening for tuberculosis prior to highly active antiretroviral therapy (HAART) initiation is not routinely performed in low-incidence settings. Identifying factors associated with developing tuberculosis after HAART initiation could focus screening efforts.
Methods. Sixteen cohorts in the United States and Canada contributed data on persons infected with human immunodeficiency virus (HIV) who initiated HAART December 1995–August 2009. Parametric survival models identified factors associated with tuberculosis occurrence.
Results. Of 37845 persons in the study, 145 were diagnosed with tuberculosis after HAART initiation. Tuberculosis risk was highest in the first 3 months of HAART (20 cases; 215 cases per 100000 person-years; 95% confidence interval [CI]: 131–333 per 100000 person-years). In a multivariate Weibull proportional hazards model, baseline CD4+ lymphocyte count <200, black race, other nonwhite race, Hispanic ethnicity, and history of injection drug use were independently associated with tuberculosis risk. In addition, in a piece-wise Weibull model, increased baseline HIV-1 RNA was associated with increased tuberculosis risk in the first 3 months; male sex tended to be associated with increased risk.
Conclusions. Screening for active tuberculosis prior to HAART initiation should be targeted to persons with baseline CD4 <200 lymphocytes/mm3 or increased HIV-1 RNA, persons of nonwhite race or Hispanic ethnicity, history of injection drug use, and possibly male sex.
doi:10.1093/infdis/jir421
PMCID: PMC3156918  PMID: 21849286
21.  Missing Data on the Estimation of the Prevalence of Accumulated Human Immunodeficiency Virus Drug Resistance in Patients Treated With Antiretroviral Drugs in North America 
American Journal of Epidemiology  2011;174(6):727-735.
Determination of the prevalence of accumulated antiretroviral drug resistance among persons infected with human immunodeficiency virus (HIV) is complicated by the lack of routine measurement in clinical care. By using data from 8 clinic-based cohorts from the North American AIDS Cohort Collaboration on Research and Design, drug-resistance mutations from those with genotype tests were determined and scored using the Genotypic Resistance Interpretation Algorithm developed at Stanford University. For each year from 2000 through 2005, the prevalence was calculated using data from the tested subset, assumptions that incorporated clinical knowledge, and multiple imputation methods to yield a complete data set. A total of 9,289 patients contributed data to the analysis; 3,959 had at least 1 viral load above 1,000 copies/mL, of whom 2,962 (75%) had undergone at least 1 genotype test. Using these methods, the authors estimated that the prevalence of accumulated resistance to 2 or more antiretroviral drug classes had increased from 14% in 2000 to 17% in 2005 (P < 0.001). In contrast, the prevalence of resistance in the tested subset declined from 57% to 36% for 2 or more classes. The authors’ use of clinical knowledge and multiple imputation methods revealed trends in HIV drug resistance among patients in care that were markedly different from those observed using only data from patients who had undergone genotype tests.
doi:10.1093/aje/kwr141
PMCID: PMC3202147  PMID: 21813792
antiretroviral therapy, highly active; drug resistance; genotype; HIV
22.  Associations among Visual Acuity and Vision- and Health-Related Quality of Life among Patients in the Multicenter Uveitis Steroid Treatment Trial 
Among uveitis patients, the vision-related function score correlated positively with visual acuity and correlated moderately positively with general quality-of-life measures.
Purpose.
To evaluate the associations between visual acuity and self-reported visual function; visual acuity and health-related quality of life (QoL) metrics; a summary measure of self-reported visual function and health-related QoL; and individual domains of self-reported visual function and health-related QoL in patients with uveitis.
Methods.
Best-corrected visual acuity, vision-related functioning as assessed by the NEI VFQ-25, and health-related QoL as assessed by the SF-36 and EuroQoL EQ-5D questionnaires were obtained at enrollment in a clinical trial of uveitis treatments. Multivariate regression and Spearman correlations were used to evaluate associations between visual acuity, vision-related function, and health-related QoL.
Results.
Among the 255 patients, median visual acuity in the better-seeing eyes was 20/25, the vision-related function score indicated impairment (median, 60), and health-related QoL scores were within the normal population range. Better visual acuity was predictive of higher visual function scores (P ≤ 0.001), a higher SF-36 physical component score, and a higher EQ-5D health utility score (P < 0.001). The vision-specific function score was predictive of all general health-related QoL (P < 0.001). The correlations between visual function score and general quality of life measures were moderate (ρ = 0.29–0.52).
Conclusions.
The vision-related function score correlated positively with visual acuity and moderately positively with general QoL measures. Cost–utility analyses relying on changes in generic healthy utility measures will be more likely to detect changes when there are clinically meaningful changes in vision-related function, rather than when there are only changes in visual acuity. (ClinicalTrials.gov number, NCT00132691.)
doi:10.1167/iovs.11-8259
PMCID: PMC3339901  PMID: 22247489
23.  Visual field loss among patients with cytomegalovirus retinitis 
Ophthalmology  2010;118(5):895-901.
Purpose
To describe visual field (VF) loss among patients with cytomegalovirus (CMV) retinitis and the risk factors for such loss.
Design
Multicenter, prospective, observational study
Participants
476 patients with AIDS and CMV retinitis and VF data
Methods
Follow-up every 3 months with medical history, ophthalmological examination, Goldman visual fields, and laboratory testing
Main outcome measures
Incidence of visual field loss in eyes affected with CMV retinitis and characteristics associated with such VF loss
Results
Over a median follow up of 4 years (range = 0.5 to 9 years), the incidence rates of VF loss to 75% and 50% of normal were 0.22/eye-year (EY, 95% confidence interval [CI]: 0.20, 0.25) and 0.08/EY (95% CI: 0.06, 0.10), respectively. The observed rates were 6- to 7-fold less than those observed rates of VF loss in the era prior to highly active antiretroviral therapy (HAART). Decreased CD4+ T cell count, whether measured at enrollment or over follow up time, was associated with increased rates of VF loss for all VF outcomes in a dose-dependent fashion. Risk factors for VF loss included lower CD4+ T cell count, CMV lesion size >25% of the total retinal area, and active CMV retinitis after controlling for potential confounding. HAART use and immune recovery (CD4+ T cell count >100 cells/μL) were associated with reduced risk of VF loss in multiple regression models. Immune recovery was statistically significantly associated with a lower risk of VF loss to 75% of normal (relative risk [RR] = 0.63 95% CI: 0.49, 0.86 P = 0.003) and to 50% of normal (RR = 0.60 95% CI: 0.44, 0.82 P = 0.001) after controlling for demographic characteristics, human immunodeficiency virus (HIV) viral load, HAART use, CMV lesion location and size, and retinitis activity.
Conclusions
Cytomegalovirus retinitis was associated with a substantial risk of incident VF loss, but the incidence is approximately 6- fold lower than that observed in the pre-HAART era. Those who have HAART-induced immune recovery have approximately 40% lower risk of visual field loss for both outcomes after controlling for confounding.
doi:10.1016/j.ophtha.2010.09.017
PMCID: PMC3087851  PMID: 21146225
24.  Adverse effects of smoking on patients with ocular inflammation 
Background
To evaluate how smoking affects the time to disease quiescence and time to disease recurrence in patients with ocular inflammation.
Methods
A retrospective cohort study of patients with ocular inflammation who were followed longitudinally and had smoking information available in the Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study database.
Results
Among 2676 patients with active ocular inflammation, smokers were more likely to have bilateral ocular disease and poorer visual acuity on presentation compared with non-smokers and previous smokers. In a multivariate analysis, there was no statistically significant difference in the time to disease quiescence between groups. However, the median time to recurrence of ocular inflammation was statistically significantly longer for non-smokers (9.4 months) and for previous smokers (10.7 months) than for current smokers (7.8 months) (p=0.02). The RR of ocular inflammation recurrence was higher for smokers than for non-smokers (adjusted HR=1.19, 95% CI 1.03 to 1.37) and tended towards significance in previous smokers (adjusted HR=1.11, 95% CI 0.93 to 1.35).
Conclusions
Smoking was associated with an increased likelihood of bilateral ocular inflammation and reduced vision upon presentation, and an increased risk of recurrence compared with not smoking. These results suggest that patients with ocular inflammation should be counselled to stop smoking as part of routine management.
doi:10.1136/bjo.2009.174466
PMCID: PMC3227535  PMID: 20606023
25.  Risk of cataract development among children with juvenile idiopathic arthritis-related uveitis treated with topical corticosteroids 
Ophthalmology  2010;117(7):1436-1441.
Purpose
To investigate the risk of cataract development among patients with juvenile idiopathic arthritis (JIA)-associated uveitis treated with topical corticosteroids.
Design
Retrospective cohort study
Participants
75 patients with JIA- associated uveitis observed from July 1984 through August 2005 at a single academic center.
Methods
Clinical data on these patients were collected by chart review and were analyzed.
Main outcome measures
Incidence of new-onset cataract. Risk factors for cataract development were assessed with attention paid to the use of topical corticosteroids.
Results
Over a median follow-up of 4 years, the incidence of new-onset cataract was 0.04/eye-year (EY, 95% confidence interval [CI]: 0.02/EY, 0.09/EY). Of the 60 eyes in 40 patients who received topical corticosteroid therapy, there was a dose-dependent increase in the rate of cataract development among eyes receiving topical corticosteroids. The incidence of cataract was 0.01/EY for eyes treated with ≤ 3 drops daily and 0.16/EY (P = 0.0006 for log rank test) for eyes treated with >3 drops daily. Among eyes receiving ≤ 2 drops daily, the incidence of cataract was 0/EY (95% CI, one-sided: 0.03/EY). Presence of posterior synechiae, active uveitis, and use of topical corticosteroids at presentation were statistically significantly associated with cataract development after controlling for confounding variables. Use of topical corticosteroids was associated with cataract formation independent of uveitis activity. Using longitudinal data analysis and controlling for duration of uveitis, presence and degree of active uveitis, and concomitant use of other forms of corticosteroids in a time-updated fashion, treatment with ≤ 3 drops daily of topical corticosteroid was associated with an 87% lower risk of cataract formation compared to eyes treated with >3 drops daily (relative risk = 0.13, 95% CI: 0.02, 0.69, P = 0.02).
Conclusions
In our cohort, topical corticosteroid use was associated with an increased risk of cataract formation independent of active uveitis or presence of posterior synechiae. However, chronic use of topical corticosteroids dosed at ≤ 3 drops daily appeared to be associated with a lower risk of cataract development relative to eyes receiving higher doses over follow up in the setting of suppressed uveitis.
doi:10.1016/j.ophtha.2009.12.003
PMCID: PMC2900491  PMID: 20363502

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