Subconjunctival versus combined subconjunctival and subscleral flap mitomycin C in pediatric trabeculectomy: a randomized clinical study

Introduction: To compare the safety and efficacy of trabeculectomy augmented by subconjunctival application of mitomycin C (MMC) vs combined subconjunctival and subscleral flap MMC application in primary congenital glaucoma (PCG). Methods: This prospective, randomized, interventional study included children aged ≤6 years, requiring a trabeculectomy for PCG. Fifty eyes were randomly assigned to undergo trabeculectomy with subconjunctival MMC application (group A, 25 eyes), or trabeculectomy with combined subconjunctival and subscleral flap MMC application (group B, 25 eyes). Success was defined as achieving an intraocular pressure (IOP) ≤18 mm Hg at 12 months, without medications (complete success) or with/without antiglaucoma medications (qualified success). Postoperative results were compared at 1, 3, 6, 9, 12 months, and the final follow-up. The main outcome measures were IOP, number of glaucoma medications, surgical success, postoperative interventions, and complications in both groups. Results: At 12 months, the percent IOP reduction for group A was 45.6% and for group B 46.8%. Qualified success was achieved in 68% and 72% of eyes in groups A and B, respectively. Failure tended to occur earlier in group B. Kaplan-Meier analysis for complete success showed cumulative probability of survival of 53% for group A and 40% for group B (P = 0.38). Needling was more successful in group B with 60 % total success compared to 33.3% in group A (P value = 0.39). Conclusion/relevance: The subscleral flap application of MMC in conjunction with subconjunctival MMC application in pediatric trabeculectomy does not appear to result in additional benefit regarding safety or efficacy, when compared to subconjunctival application alone.