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Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
A comparison of treatment approaches for bilateral congenital nasolacrimal duct obstruction.
American Journal of Ophthalmology 2013 November
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.
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.
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