PURPOSE: To compare outcomes of trabeculectomy combined with mitomycin C (MMC) and amniotic membrane transplantation (AMT) with those of trabeculectomy with MMC alone in refractory glaucoma. METHODS: This prospective, randomized study included 37 eyes with refractory glaucoma at such high risks as neovascular, pseudophakic, and prior failure. Trabeculectomy with MMC and single-layer AMT under the scleral flap was performed in 19 eyes and trabeculectomy with MMC alone in 18 eyes. The outcome measures included intraocular pressure (IOP), number of antiglaucoma medications, and complications. All patients were followed for 12 months. RESULTS:Complete success (IOP <22 mm Hg without glaucoma medications) was seen in 15/16 (93.7%) study eyes and 9/15 (60%) control eyes at 6 months postoperatively (P=0.03), and in 12/15 (80%) and 6/15 (40%) at 12 months after surgery, respectively (P=0.03). IOP decreased from 45.6+/-12.7 mm Hg and 44.9+/-10.7 mm Hg preoperatively in study and control groups to 15.3+/-2.3 mm Hg and 21.3+/-3.8 mm Hg, respectively, at 12 months (P<0.0001). Early postoperative hypotony developed in 3 (16.7%) control eyes owing to excessive filtration but none of study eyes (P=0.1). Encapsulated bleb occurred in 7 (38.9%) control eyes but in 1 (5.3%) study eye (P=0.02). CONCLUSIONS: In refractory glaucoma, trabeculectomy combined with MMC and AMT compared to trabeculectomy with MMC alone has higher success rates, lower postoperative mean IOPs, and less complication rates.
RCT Entities:
PURPOSE: To compare outcomes of trabeculectomy combined with mitomycin C (MMC) and amniotic membrane transplantation (AMT) with those of trabeculectomy with MMC alone in refractory glaucoma. METHODS: This prospective, randomized study included 37 eyes with refractory glaucoma at such high risks as neovascular, pseudophakic, and prior failure. Trabeculectomy with MMC and single-layer AMT under the scleral flap was performed in 19 eyes and trabeculectomy with MMC alone in 18 eyes. The outcome measures included intraocular pressure (IOP), number of antiglaucoma medications, and complications. All patients were followed for 12 months. RESULTS: Complete success (IOP <22 mm Hg without glaucoma medications) was seen in 15/16 (93.7%) study eyes and 9/15 (60%) control eyes at 6 months postoperatively (P=0.03), and in 12/15 (80%) and 6/15 (40%) at 12 months after surgery, respectively (P=0.03). IOP decreased from 45.6+/-12.7 mm Hg and 44.9+/-10.7 mm Hg preoperatively in study and control groups to 15.3+/-2.3 mm Hg and 21.3+/-3.8 mm Hg, respectively, at 12 months (P<0.0001). Early postoperative hypotony developed in 3 (16.7%) control eyes owing to excessive filtration but none of study eyes (P=0.1). Encapsulated bleb occurred in 7 (38.9%) control eyes but in 1 (5.3%) study eye (P=0.02). CONCLUSIONS: In refractory glaucoma, trabeculectomy combined with MMC and AMT compared to trabeculectomy with MMC alone has higher success rates, lower postoperative mean IOPs, and less complication rates.