A Reibaldi1, M G Uva, A Longo. 1. Eye Clinic, University of Catania, Via Santa Sofia 78, Catania, Italy.
Abstract
AIM: To evaluate the long-term efficacy and safety of trabeculectomy with or without low-dosage Mitomycin-C (MMC) in primary open-angle glaucoma (POAG). METHODS:114 patients affected by POAG, participating in a randomised clinical trial from 1995 to 1998, were re-examined and their chart reviewed. Patients had undergone in one eye a trabeculectomy with intraoperative application (2 min) ofMMC (0.2 mg/ml) or balanced saline solution (BSS), and, if indicated, postoperative laser suture lysis, bleb needling and/or digital massage. Intraocular pressure (IOP), medical therapy, visual field, further glaucoma surgery, cataract surgery and complication rate (leakage, cataract progression, hypotony, blebitis, endophthalmitis) were evaluated. RESULTS:67 eyes had received MMC and 47 BSS. MMC-treated eyes had a lower mean IOP (13.33+/-3.35 vs 14.72+/-2.19 mm Hg, p = 0.014); in this group, an higher percentage of eyes had IOP < or = 18 mm Hg (73.1% vs 51.1%, p = 0.027) and IOP < or = 14 mm Hg (56.7% vs 31.9%, p = 0.015); a lower rate had further glaucoma surgery (9% vs 25.5%, p = 0.040), and visual-field damage progression (21.1% vs 48.6%, p = 0.009). No difference was seen in the complication rate: one MMC-treated eye developed blebitis. CONCLUSIONS: In POAG low-dose MMC with intensified postoperative management improved the outcome of the trabeculectomy with a low incidence of complications.
RCT Entities:
AIM: To evaluate the long-term efficacy and safety of trabeculectomy with or without low-dosage Mitomycin-C (MMC) in primary open-angle glaucoma (POAG). METHODS: 114 patients affected by POAG, participating in a randomised clinical trial from 1995 to 1998, were re-examined and their chart reviewed. Patients had undergone in one eye a trabeculectomy with intraoperative application (2 min) of MMC (0.2 mg/ml) or balanced saline solution (BSS), and, if indicated, postoperative laser suture lysis, bleb needling and/or digital massage. Intraocular pressure (IOP), medical therapy, visual field, further glaucoma surgery, cataract surgery and complication rate (leakage, cataract progression, hypotony, blebitis, endophthalmitis) were evaluated. RESULTS: 67 eyes had received MMC and 47 BSS. MMC-treated eyes had a lower mean IOP (13.33+/-3.35 vs 14.72+/-2.19 mm Hg, p = 0.014); in this group, an higher percentage of eyes had IOP < or = 18 mm Hg (73.1% vs 51.1%, p = 0.027) and IOP < or = 14 mm Hg (56.7% vs 31.9%, p = 0.015); a lower rate had further glaucoma surgery (9% vs 25.5%, p = 0.040), and visual-field damage progression (21.1% vs 48.6%, p = 0.009). No difference was seen in the complication rate: one MMC-treated eye developed blebitis. CONCLUSIONS: In POAG low-dose MMC with intensified postoperative management improved the outcome of the trabeculectomy with a low incidence of complications.