PURPOSE: To examine if the addition of (antegrade) balloon dacryocystoplasty to bicanalicular silicone intubation affects the success rate in adults with incomplete nasolacrimal duct (NLD) obstruction. DESIGN: Prospective, randomized trial. METHODS:Seventy eyes of 70 patients with incomplete NLD obstruction and severe epiphora (Munk score grade 3 or 4) were treated randomly with dacryocystoplasty (Lacricath) and silicone intubation (Ritleng; n = 35, group 1; mean age, 54.4 years; standard deviation [SD], 11.8 years) or silicone intubation alone (n = 35, group 2; mean age, 53.5 years; SD, 13.1 years; P > .05). The silicone tubes were removed after, on average, three months. At the visit, we assessed the grade of epiphora using the Munk score. Complete success was defined as Munk score of 0 or 1, partial success was defined as Munk score of 2, and failure was defined as Munk score of 3 or 4. Long-term Munk scores were obtained through a telephone survey nine to 76 months after surgery (mean, 43.4 in group 1 and 34.9 in group 2; P > .05). RESULTS:Complete success was reported by 18 patients (52%) in group 1 and by 20 patients (57%) in group 2. Partial success was reported by one patient in group 1 and by one patient in group 2. No improvement was reported by 15 patients (44%) in group 1 and by 14 patients (40%) in group 2. Differences between the two groups proved to be not significant (P = .8, exact Chi-square trend test). CONCLUSIONS: In our patients with acquired partial NLD obstruction, treatment with a combination of antegrade dacryocystoplasty and silicone intubation was not associated with a higher success rate compared with treatment with silicone intubation alone.
RCT Entities:
PURPOSE: To examine if the addition of (antegrade) balloon dacryocystoplasty to bicanalicular silicone intubation affects the success rate in adults with incomplete nasolacrimal duct (NLD) obstruction. DESIGN: Prospective, randomized trial. METHODS: Seventy eyes of 70 patients with incomplete NLD obstruction and severe epiphora (Munk score grade 3 or 4) were treated randomly with dacryocystoplasty (Lacricath) and silicone intubation (Ritleng; n = 35, group 1; mean age, 54.4 years; standard deviation [SD], 11.8 years) or silicone intubation alone (n = 35, group 2; mean age, 53.5 years; SD, 13.1 years; P > .05). The silicone tubes were removed after, on average, three months. At the visit, we assessed the grade of epiphora using the Munk score. Complete success was defined as Munk score of 0 or 1, partial success was defined as Munk score of 2, and failure was defined as Munk score of 3 or 4. Long-term Munk scores were obtained through a telephone survey nine to 76 months after surgery (mean, 43.4 in group 1 and 34.9 in group 2; P > .05). RESULTS: Complete success was reported by 18 patients (52%) in group 1 and by 20 patients (57%) in group 2. Partial success was reported by one patient in group 1 and by one patient in group 2. No improvement was reported by 15 patients (44%) in group 1 and by 14 patients (40%) in group 2. Differences between the two groups proved to be not significant (P = .8, exact Chi-square trend test). CONCLUSIONS: In our patients with acquired partial NLD obstruction, treatment with a combination of antegrade dacryocystoplasty and silicone intubation was not associated with a higher success rate compared with treatment with silicone intubation alone.