RANDOMIZED CONTROLLED TRIAL
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[Comparison of balloon catheter dilatation and silicon intubation as the secondary treatment for congenital nasolacrimal duct obstruction after failed primary probing].

OBJECTIVE: To determine the success rates and compare the results of balloon catheter dilation and nasolacrimal intubation as treatment for congenital nasolacrimal duct obstruction after failed probing, stratified by category of age and type of obstruction.

METHODS: It was a prospective, randomized, clinical trial that enrolled 189 children (245 eyes) aged between 6 months to 48 months who had a history of failed nasolacrimal duct probing. All eyes underwent either balloon catheter nasolacrimal duct dilation or nasolacrimal duct intubation randomly. The eyes were divided into 2 age categories: category 1 (6-24 months) and category 2 (>24 months) and into 2 types of obstructions: simple obstruction and complex obstruction. Treatment success was defined as absence of epiphora, mucous discharge, or increased lacrimal lake at the outcome visit 6 months after surgery. Complications were also compared.

RESULTS: In 124 eyes treated with balloon catheter dilatation, 112 were successful (90.3%) comparing with 106 successful eyes (87.6%) in 121 eyes treated with nasolacrimal duct intubation. The risk ratio for success between intubation and balloon dilation was 0.971, and the 95% confidence interval was 0.95-1.22. Within each age category, the success rate varied but did not show significant difference: In those under 24 months, success rate was 89.7% in 97 eyes treated with intubation, and 91.9% in 99 eyes treated with balloon dilation (RR, 0.976; 95% CI, 0.590-0.956). In those above 24 months, success rate was 79.1% in 24 eyes treated with intubation, and 84.0% in 25 eyes treated with balloon dilation (RR, 0.942; 95%CI, 0.813-1.387). In the group of simple obstruction, success rate was 96.5% in 87 eyes treated with intubation, and 93.1% in 88 eyes treated with balloon dilation (RR, 1.036; 95% CI, 0.967-1.105). In the group of complex obstruction, Success rate was 64.7% in 34 eyes treated with intubation, and 86.1% in 36 eyes treated with balloon dilation. The success rate of balloon dilatation showed slightly higher than that of intubation (RR, 0.751; 95% CI, 0.590-0.956). There were 59 eyes showed complications in intubation group, while only 2 eyes in balloon dilation group.

CONCLUSIONS: Both balloon catheter dilation and nasolacrimal duct intubation could alleviate the clinical signs of persistent nasolacrimal duct obstruction with a similar percentage of patients. In the complex obstruction group, balloon catheter dilation showed better efficacy than nasolacrimal duct intubation.

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