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To determine how often nasolacrimal duct obstruction (NLDO) resolves with 6 months of nonsurgical management in infants aged 6 to <10 months old.
As part of a randomized trial evaluating the cost effectiveness of immediate office probing versus observation with deferred probing for unresolved cases, 107 infants aged 6 to <10 months old who had NLDO and no history of prior nasolacrimal duct surgery were prescribed 6 months of nasolacrimal duct massage and topical antibiotics as needed. Resolution of the nasolacrimal duct obstruction was assessed 6 months after study entry and was defined as the absence of all clinical signs of NLDO (epiphora, increased tear lake, or mucous discharge) and not having undergone NLDO surgery. Exploratory analyses assessed whether baseline characteristics including age, gender, laterality, and prior treatment were associated with the probability of NLDO resolving without surgery.
At the 6-month examination, which was completed for 117 of the 133 eyes (88%), the NLDO had resolved without surgery in 77 eyes (66%, 95% CI = 56% to 74%). None of the baseline characteristics we evaluated were found to be associated with resolution.
In infants 6 to < 10 months of age, more than half of eyes with NLDO resolve within 6 months with nonsurgical management. Knowledge of the rate of NLDO resolution in infancy without surgery will help clinicians and parents effectively discuss treatment options.
Nasolacrimal duct obstruction (NLDO) is a common ocular condition in infants. The reported rate of NLDO resolution without surgery ranges from 32% to 95% by age 13 months.1–5 However, most of the studies are retrospective, have poor follow-up, and/or include cases of resolution within the first few months of life. Because surgical treatment is rarely considered before 6 months of age, knowing how often NLDO resolves without surgery in patients with symptoms persisting beyond 6 months of age is of clinical interest.
We recently conducted a multicenter randomized trial comparing the cost effectiveness of two approaches for treating children with NLDO symptoms persisting past age 6 months: immediate probing in an office setting versus 6 months of nonsurgical management followed by deferred probing under general anesthesia for unresolved cases. Herein we report the frequency of resolution without surgery in 107 children (133 eyes) 6 to <10 months old who were prescribed 6 months of lacrimal sac massage and topical antibiotics as needed for treatment of NLDO.
This randomized trial, supported through a cooperative agreement with the National Eye Institute of the National Institutes of Health, was conducted by the Pediatric Eye Disease Investigator Group (PEDIG) at 22 academic and community-based ophthalmology practices. The protocol and Health Information Portability and Accountability Act of 1996-compliant informed consent forms were approved by the respective institutional review boards. The parent or guardian of each study subject gave written informed consent. The study is listed on www.clinicaltrial.gov under identifier NCT00780741. The protocol is available on the PEDIG website (www.pedig.net, accessed October 25, 2011). Eligibility criteria for the trial and the protocol for the observation/deferred probing group are summarized herein.
Major eligibility criteria for the randomized trial included age 6 to <10 months; onset of NLDO symptoms prior to 6 months of age; presence of at least one sign of NLDO (epiphora, increased tear lake, and/or mucopurulent discharge in the absence of an upper respiratory infection, ocular surface irritation, or glaucoma); and no prior nasolacrimal duct surgery including simple probing, nasolacrimal intubation, balloon catheter dilation, or dacryocystorhinostomy. Prior NLDO treatment with nasolacrimal sac massage, topical antibiotics or steroids, or systemic antibiotics was permitted. Children with Down syndrome or craniofacial anomalies were excluded.
Children assigned to the observation/deferred facility probing group were prescribed 6 months of nonsurgical management consisting of twice-daily lacrimal sac massage (gentle inward pressure applied to the lacrimal sac for 2–3 seconds) to be performed when discharge was present and antibiotic drops supplied at randomization (investigator choice of tobramycin sulfate 0.3% or moxifloxacin 0.5%) were to be used (1 drop up to 4 times a day) when discharge was purulent. Per protocol, surgery was not to be performed before the completion of 6 months of follow-up. A telephone contact was made 3 months (±2 weeks) after randomization to inquire whether symptoms were still present. Follow-up examinations to assess for the presence of epiphora, increased tear lake, and/or mucous discharge were performed 6 months (±2 weeks) after enrollment and at 18 months of age (± 4 weeks). Subjects who had one or more clinical sign of NLDO present at the 6-month visit (occurring at 12 to < 16 months of age) were to undergo an NLD probing procedure performed under general anesthesia in a surgical facility within 4 weeks.
Resolution was defined as absence of clinical signs of NLDO (epiphora, increased tear lake, or mucous discharge) on clinical examination and not having undergone NLDO surgery. The proportion of eyes with resolution of NLDO without surgery after 6 months of observation and nonsurgical management and a 95% confidence interval were calculated using logistic regression with generalized estimating equations to adjust for the correlation between eyes of subjects with two study eyes.6 The primary analysis included only subjects who completed the 6 month visit. For a secondary analysis including all subjects, multiple imputations with the logistic regression method7 were used to impute a 6-month outcome based on 3-month data for 15 subjects who missed the 6-month visit. The associations of 6-month resolution without surgery and baseline demographic and clinical characteristics were assessed by estimating relative risks using Poisson regression8 and using generalized estimating equations (GEE) to adjust for the correlation between eyes of subjects with two study eyes.6
All analyses were conducted using SAS version 9.1. (SAS Institute Inc. Cary, NC).
The 107 subjects (133 eyes) who were prescribed 6 months of nonsurgical management ranged in age from 6.0 months to 10.0 months with a mean age of 7.8 months. Fifty-three (50%) subjects were female and 87 (81%) were white. Eighty-one patients (76%) had unilateral NLDO and 26 (24%) had bilateral NLDO. One-hundred fifteen of the 133 eyes (87%) had been treated with lacrimal sac massage and/or topical antibiotics before entering the study.
Four subjects (4 eyes) had surgery during the 6-month nonsurgical management period, two in the first month and two in the second month. Early surgery was performed due to development of cellulitis (N=1) or at parent request due to continuing or worsening symptoms (N=3).
The 3-month telephone call was completed by the parents of 106 (99%) subjects. Fifty-nine of 132 eyes (46%, 95% CI = 37% to 55%) were reported to be asymptomatic.
At the visit 6 months after enrollment, completed by 92 (86%) subjects, 77 of 117 eyes (66%, 95% CI = 56% to 74%) had resolved without surgery (Table 1). Of the 16 eyes of the 15 patients who did not complete the 6-month visit, 3 had undergone surgery within 6 months of enrollment, 5 were symptomatic at 3 months, and 8 were not symptomatic at 3 months (Figure 1). Among the 25 subjects who had bilateral NLDO, 14 (56%, 95% CI = 37% to 74%) had both eyes resolve without surgery at 6 months.
The secondary analysis using multiple imputation for eyes of subjects who missed the 6-month visit yielded similar results (probability of an eye to resolve without surgery = 64%, 95% CI = 54% to 73%).
Baseline demographic and clinical characteristics including age, gender, laterality, and prior treatment were not found to be associated with 6-month resolution without surgery (Table 2).
Of the 77 eyes that showed no signs of NLDO at the 6-month post-enrollment visit, an additional examination was performed at approximately 18 months of age (1 to 4 months after the 6-month visit depending on the subject’s age at study enrollment); 63 eyes (82%) had no signs of NLDO, 12 (16%) had clinical signs of NLDO, and 2 (3%) had undergone surgery.
As part of a randomized treatment trial of two approaches for treating NLDO, we assessed how often the condition resolves with nonsurgical management in infants with symptoms present at 6 to <10 months of age, the age range at which nasolacrimal duct probing in an office setting is considered feasible. We found that during the 6-month period of observation with lacrimal sac massage and topical antibiotics used as needed, about half of eyes were reported by parents to be asymptomatic by 3 months and about two-thirds of eyes were free of signs of NLDO by a clinical assessment at 6 months.
Although several studies in the literature report rates of NLDO resolution with nonsurgical management, 1–5 we are aware of only one which specifically reports resolution in patients with symptoms persisting past 6 months of age. In a prospective study of infants with symptoms persisting to age 6 months, Paul reported that 70% of eyes (26 of 37) resolved with conservative treatment by 12 months of age,4 a proportion which would correspond to a 95% confidence interval of 55% to 85%. Our estimate of 66% (95% CI = 56% to 74%), obtained from a larger sample size, is consistent with this previous estimate.4
None of the baseline characteristics we evaluated---age, gender, laterality, specific clinical signs of NLDO, and prior treatment--were found to be associated with resolution of nasolacrimal duct obstruction without surgery. These sub-analyses can only be considered exploratory because our small sample size limited our ability to detect an association unless it was very strong.
It is of interest that nearly 20% of eyes in which NLDO appeared on exam to have resolved after 6 months of nonsurgical management showed signs of NLDO when reassessed 1 to 4 months later at 18 months of age. It is possible that symptoms and signs of NLDO are intermittent and that despite appearing clear of signs on a given day, some eyes might have NLDO that would require surgery. Another possibility is that NLDO signs observed at a given visit might be produced or exacerbated by wind, direct sunlight, or the presence of an upper respiratory illness.
The strengths of this study include its prospective design and a standardized period of follow-up, however several factors should be considered when interpreting our results. First, our rate of patient retention was lower than expected. Second, although our estimate of an eye’s probability of 6-month resolution without surgery is more precise than those from previous studies, the confidence interval is still fairly wide. Third, because patients with bilateral NLDO would still require surgery if only one eye resolves, how often both eyes resolve in 6 months without surgery may be of greater interest. Although we observed this proportion to be 56%, we cannot draw a definitive conclusion because the confidence interval is very wide (37% to 74%) due to the small number of bilateral NLDO patients. Fourth, there is potential for misclassification of outcome based on the presence or absence of signs at a single outcome visit. Fifth, the frequency and type of the nonsurgical treatment might potentially impact the resolution rate. The study did not assess compliance with lacrimal massage or antibiotics, therefore we cannot assess whether potential lack of compliance may have lowered the resolution rate we observed. It is also possible that our rate of resolution might have been higher had the lacrimal massage regimen been more intensive, been specifically demonstrated to parents, or used the Crigler method of hydrostatic lacrimal massage,9 a method which has been shown to be more effective than simple massage.10 Finally, without a control group we are not able to determine to what extent resolution was related to the lacrimal massage, antibiotics, or the passage of time.
Knowing that more than half of NLDO cases in infants 6 to < 10 months of age will resolve within 6 months with nonsurgical management is an important component in comparing early versus deferred surgery treatment approaches and should help clinicians and parents more effectively discuss treatment options.
Supported by National Eye Institute of National Institutes of Health, Department of Health and Human Services EY011751 and EY018810.
Alcon Laboratories, Inc. provided antibiotic eyedrops and antibiotic/steroid eyedrops at no cost to the study. The sole purpose was to standardize the drugs used in study; no comparisons were made between drugs. The company did not have any input into the study design, analyses, or manuscript preparation.
Supported by National Eye Institute of National Institutes of Health, Department of Health and Human Services EY011751 and EY018810. The funding organization approved the protocol but had no role in the conduct of the study; collection, management, analysis and interpretation of the data; or preparation, review, and approval of the manuscript.
Writing committee: Lead Authors: David B. Petersen, MD1; Danielle L. Chandler, MSPH2; Michael X. Repka, MD, MBA3 Additional writing committee members (alphabetical): Roy W. Beck MD, PhD2; Eric R. Crouch III, MD4; Katherine A. Lee, MD, PhD5; Michele Melia, ScM2; David G. Morrison, MD6; Faruk H. Orge, MD7; Benjamin H. Ticho, MD8
Sites are listed in order by number of subjects enrolled into the study. Personnel are listed as (I) for Investigator, (C) for Coordinator, and (E) for Examiner.
Erie PA - Pediatric Ophthalmology of Erie
Nicholas A. Sala, (I); Rhonda M. Hodde, (C); Veda L. Zeto, (C)
Boise ID – St. Luke’s Children’s Ophthalmology
Katherine A. Lee, (I); Bonita R. Schweinler, (C); Larry W Plum, (E)
Salt Lake City UT - Rocky Mountain Eye Care Associates
David B. Petersen, (I); J. Ryan McMurtrey, (C)
Providence RI - Pediatric Ophthalmology and Strabismus Associates
David Robbins Tien, (I); Gi H. Yoon-Huang, (I); Myra B. McGuinness, (C); Jessica M De La Rosa, (C); Colleen M Bailey, (E); Jo Ann Marinaro, (E)
Chicago Ridge IL - The Eye Specialists Center, L.L.C.
Benjamin H. Ticho, (I); Alexander J. Khammar, (I); Deborah A. Clausius, (C); James B Coletta, (C); Barbara C. Imler, (E)
Columbus OH - Pediatric Ophthalmology Associates, Inc. at Nationwide Children’s Hospital **
Don L. Bremer, (I); Cybil M. Cassady, (I); Richard P. Golden, (I); Mary Lou McGregor, (I); David L. Rogers, (I); Gary L. Rogers, (I); Rae R. Fellows, (C); Meghan C McMillin, (C); Teresa M. Rinehart, (C); Amy J Wagner, (C); Jenny A Brendez, (E); Rich E Cox, (E)
Dallas TX - Children’s Medical Center*
David R. Weakley Jr., (I); Clare L. Dias, (C); Xiaowei W Zhang, (C)
Norfolk VA - Eastern Virginia Medical School
Earl R. Crouch, (I); Eric R. Crouch, (I); Gaylord G. Ventura, (C)
Nashville TN - Vanderbilt Eye Center*
David G. Morrison, (I); Lisa A. Fraine, (C); Ronald J. Biernacki, (E); Christine C. Franklin, (E); Kelsie J. Haskins, (E)
Cranberry TWP PA - Everett and Hurite Ophthalmic Association
Darren L. Hoover, (I); Pamela A. Huston, (C)
Atlanta GA - Emory University
Scott R. Lambert, (I); Amy K. Hutchinson, (I); Phoebe D Lenhart, (I); Marla J. Shainberg, (C); Rachel A. Robb, (C); Natario L Couser, (E)
Concord NH - Concord Eye Care P.C.
Christie L. Morse, (I); Caroline C. Fang, (C); Melanie L. Christian, (C); Virginia X. Karlsson, (E)
Cleveland OH - Cole Eye Institute*
Elias Traboulsi, (I); Paul J Rychwalski, (I); Susan W. Crowe, (C)
Lancaster PA - Family Eye Group
David I. Silbert, (I); Eric L. Singman, (I); Noelle S. Matta, (C); Garry L. Leckemby, (E); Michael R Pavlica, (E)
Minneapolis MN - University of Minnesota*
C. Gail Summers, (I); Erick D. Bothun, (I); Inge De Becker, (I); Ann M. Holleschau, (C); Anna I. de Melo, (E); Kathy M. Hogue, (E); Kim S. Merrill, (E)
Tomball TX - Houston Eye Associates
Aaron M. Miller, (I); Jorie L. Jackson, (C); Suzanne S LaRiviere, (E)
Albuquerque NM - Family & Children’s Eye Center of New Mexico
Todd A. Goldblum, (I); Angela Alfaro, (C)
Springfield MO - St. John’s Clinic - Eye Specialists
Scott Atkinson, (I); Crystal L. Trythall, (C); Angela B. Hendrickson, (E)
Arnold MD - Ophthalmology Associates of Greater Annapolis
John M. Avallone, (I); Charlene R Bryant, (C); Wanda E Peyton, (E)
Cleveland OH - Rainbow Babies & Children’s Hospital Dept of Ophth
Faruk H. Orge, (I); Sara E. Schoeck, (I); Beth J. Colon, (C); Nina X. Mar, (C); Reena S. Vaswani, (E)
Lancaster MA - D’Ambrosio Eye Care
Oren L. Weisberg, (I); Shannon M. Giansanti, (C); Julie M. Kaddy, (C)
Raymond T. Kraker, Roy W. Beck, Christina M. Cagnina-Morales, Danielle L. Chandler, Laura E. Clark, Chelsea Costa, Elise R. Diamond, Quayleen Donahue, Brooke P. Fimbel, Nicole C. Foster, Elizabeth L. Lazar, Stephanie V. Lee, Lee Anne Lester, B. Michele Melia, Pamela S. Moke, Diana E. Rojas
Donald F. Everett
Michael X. Repka, Katherine A. Lee, Jonathan M. Holmes, Danielle L. Chandler, Kevin Frick, David I. Silbert, Nicholas A. Sala, Darren L. Hoover, Roy W. Beck
Katherine A. Lee, Michael X. Repka, Jonathan M. Holmes, Danielle L. Chandler, Donald F. Everett, Veda Lori Zeto, Rae Fellows, and all participating investigators.
Jonathan M. Holmes (Chair), Roy W. Beck, Eileen E. Birch, Donald F. Everett, Raymond T. Kraker, Michael X. Repka, Susan A. Cotter, David K. Wallace, David B. Petersen (2010-present), Laura Enyedi (2011-present), Darren L. Hoover (2008, 2011-present), David L. Rogers (2011-present), Aaron M. Miller (2011-present), Jorie L. Jackson (2011-present), Marjean T. Kulp, (2010-present), Benjamin H. Ticho (2010-present), Eric R. Crouch III (2010–2011), Darron Bacal (2009–2010), Robert Rutstein (2009–2010), Stephen Christiansen (2008–2010), Pamela Huston (2008–2009), Katherine A. Lee (2008–2009), Noelle S. Matta (2008–2009), David Morrison (2008–2009), Mitchell Scheiman (2008)
Marie Diener-West (Chair), John D. Baker, Barry Davis, Velma Dobson (2008–2010), Donald F. Everett, Dale L. Phelps, Stephen Poff, Richard A. Saunders, Lawrence Tychsen
The authors have no potential conflicts of interest.
1Rocky Mountain Eye Care Associates, Salt Lake City, UT
2Jaeb Center for Health Research, Tampa, FL
3Wilmer Ophthalmological Institute, Johns Hopkins University, Baltimore, MD
4Eastern Virginia Medical School, Norfolk, VA
5St. Luke’s Children’s Ophthalmology, Boise, ID
6Vanderbilt University Eye Center, Nashville, TN
7Rainbow Babies & Children’s Hospital Dept of Ophthalmology, Cleveland, OH
8The Eye Specialists Center, L.L.C., Chicago Ridge, IL
*Center received support utilized for this project from an unrestricted grant from Research to Prevent Blindness Inc., New York, New York.
**Center received support utilized for this project from an unrestricted grant support from the Ohio Lions Eye Research Foundation, Bellville, Ohio.