A comparison of treatment approaches for bilateral congenital nasolacrimal duct obstruction

Katherine A. Lee, Danielle L. Chandler, Michael X. Repka, Michele Melia, Roy W. Beck, Carole G Summers, Kevin D. Frick, Nicole C. Foster, Raymond T. Kraker, Scott Atkinson

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

Purpose To compare the clinical outcomes of two treatment approaches for bilateral nasolacrimal duct obstruction (NLDO) in infancy. Design Multicenter, randomized clinical trial. Methods We studied 57 infants between the ages of 6 and <10 months who had bilateral NLDO. Participants were randomized to receive either (1) immediate office-based probing within two weeks (n = 31) or (2) 6 months of observation and nonsurgical management followed by surgical facility-based probing for unresolved cases (n = 26). Treatment success was defined as the absence of clinical signs of NLDO (epiphora, increased tear lake, mucous discharge) in both eyes on masked examination at 18 months of age. Results In the observation and deferred facility probing group, resolution without surgery occurred by 6 months after randomization in both eyes for 14 participants (56%), in one eye for 5 (20%), and in neither eye for 6 (24%). Eight participants in the observation and deferred facility probing group underwent facility probing (one of whom later had a second facility probing). Four participants in the immediate office probing group later underwent an additional procedure in a surgical facility. In the immediate office probing group, treatment success at 18 months of age occurred in both eyes for 19 of 29 (66%) participants and in one eye for 3 (10%); in the observation and deferred facility probing group, treatment success occurred in both eyes for 19 of 25 (76%) participants and in one eye for 3 (12%) (difference in success = -10%; 95% CI = -35% to 14%). Conclusions Both the immediate office probing approach and the observation and deferred facility probing approach are successful and reasonable treatment options for infants with bilateral NLDO.

Original languageEnglish (US)
Pages (from-to)1045-1050
Number of pages6
JournalAmerican journal of ophthalmology
Volume156
Issue number5
DOIs
StatePublished - Nov 2013

Bibliographical note

Funding Information:
The study was supported through a cooperative agreement with the National Eye Institute of the National Institutes of Health and was conducted by the Pediatric Eye Disease Investigator Group (PEDIG) at 22 academic and community-based pediatric ophthalmology practices. The protocol and Health Insurance Portability and Accountability Act (HIPAA) compliant informed-consent forms were approved by institutional review boards, and a parent or guardian of each patient in the study gave written informed consent. The study is listed at www.clinicaltrials.gov ( NCT00780741 ). Key aspects of the protocol have been published. 1 The full protocol is available on the PEDIG website ( www.pedig.net ) and is briefly described below.

Funding Information:
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest, and the following were reported. Supported by National Eye Institute of the National Institutes of Health , Department of Health and Human Services , EY011751 and EY018810 . Alcon Laboratories, Inc, provided antibiotic eyedrops and antibiotic and steroid eyedrops at no cost to the study. Dr Lee received support for travel to meetings for the study of other purposes and payment for writing or reviewing the manuscript from the Jaeb Center for Health Research. Ms Chandler's institution received money from a grant from the National Eye Institute . Dr Repka's institution received a grant from the National Eye Institute and consultancy for American Academy of Ophthalmology. His institution also received money for support for travel to meetings for the study of other purposes, fees for participation in review activities, such as data monitoring boards, statistical analysis, etc, and payment for writing or reviewing the manuscript from the Jaeb Center for Health Research. Ms Melia's institution received a grant from the National Eye Institute and was paid for a board membership (Thomas Jefferson University; Alimera Science) and employment by the Jaeb Center for Health Research. Dr Frick received consulting fees or honoraria from the Jaeb Center for Health Research . Dr Beck's institution received a grant from the National Eye Institute . Dr Summers received consultancy fees from BioMarin and Plancon. Ms Foster's institution received a grant from the National Eye Institute . Mr Kraker's institution received money from a National Eye Institute grant. Dr Atkinson had no conflict of interests. Conception and design of study (K.A.L., D.L.C., M.X.R., R.T.K.); Analysis and interpretation (D.L.C., M.X.R., M.M., R.W.B., N.C.F.); Writing article (K.A.L., D.L.C., M.X.R.); Critical revisions (K.A.L., D.L.C., M.X.R., M.M., R.W.B., C.G.S., K.D.F., S.A.); Final approval (K.A.L., D.L.C., M.X.R., M.M., R.W.B., C.G.S., K.D.F., R.T.K., S.A.); Data collection (K.A.L., M.X.R., C.G.S., R.T.K., S.A.); Provision of materials, patients, or resources (K.A.L., R.T.K.); Statistical expertise (D.L.C., M.M., R.W.B., N.C.F.); Obtaining funding (R.T.K.); Literature search (M.X.R.); Administrative, technical, or logistic support (R.T.K.). A complete list of members of the Pediatric Eye Disease Investigator Group (PEDIG) can be found in a previous publication. 1

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