PURPOSE: To compare trabeculectomy with mitomycin C (T+MMC) and Ahmed glaucoma implant with MMC (AGI+MMC) in treatment of aphakic glaucoma in children below 16 years of age. DESIGN: Randomized clinical trial. PARTICIPANTS: Subjects less than 16 years of age who had previously undergone anterior lensectomy and vitrectomy for treatment of congenital cataract with unresponsive aphakic glaucoma (at least on 2 medications) were allocated in 2 groups: trabeculectomy with MMC (group A, 15 eyes) and AGI (group B, 15 eyes). METHODS: Fifteen eyes in each group underwent T+MMC or AGI+MMC. Complete and qualified success were defined as 5< or =intraocular pressure< or =21 mm Hg without and with medication, respectively. MAIN OUTCOME MEASURES: Intraocular pressure, visual acuity, and complications. RESULTS:Complete and qualified success rates were 33.3% and 40% in T+MMC group versus 20% and 66.7% in AGI+MMC group, respectively (P=0.36). Mean follow-up was 14.8 and 13.1 months and complication rates were 40% and 26.7% (P=0.44), respectively. CONCLUSIONS:T+MMC and AGI+MMC are comparable in terms of success rate and complications in pediatric aphakic glaucoma. PRECIS: This randomized clinical trial demonstrated comparable safety and efficacy for MMC trabeculectomy and AGI in the treatment of pediatric aphakic glaucoma.
RCT Entities:
PURPOSE: To compare trabeculectomy with mitomycin C (T+MMC) and Ahmed glaucoma implant with MMC (AGI+MMC) in treatment of aphakic glaucoma in children below 16 years of age. DESIGN: Randomized clinical trial. PARTICIPANTS: Subjects less than 16 years of age who had previously undergone anterior lensectomy and vitrectomy for treatment of congenital cataract with unresponsive aphakic glaucoma (at least on 2 medications) were allocated in 2 groups: trabeculectomy with MMC (group A, 15 eyes) and AGI (group B, 15 eyes). METHODS: Fifteen eyes in each group underwent T+MMC or AGI+MMC. Complete and qualified success were defined as 5< or =intraocular pressure< or =21 mm Hg without and with medication, respectively. MAIN OUTCOME MEASURES: Intraocular pressure, visual acuity, and complications. RESULTS: Complete and qualified success rates were 33.3% and 40% in T+MMC group versus 20% and 66.7% in AGI+MMC group, respectively (P=0.36). Mean follow-up was 14.8 and 13.1 months and complication rates were 40% and 26.7% (P=0.44), respectively. CONCLUSIONS: T+MMC and AGI+MMC are comparable in terms of success rate and complications in pediatric aphakic glaucoma. PRECIS: This randomized clinical trial demonstrated comparable safety and efficacy for MMC trabeculectomy and AGI in the treatment of pediatric aphakic glaucoma.