Noa Geffen1, Michael Mimouni, Mark Sherwood, Ehud I Assia. 1. *Department of Ophthalmology, Meir Medical Center, Kfar Saba †The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv ‡Department of Ophthalmology, Rambam Health Care Campus, Haifa, Israel §Department of Ophthalmology, University of Florida, Gainesville, FL.
Abstract
PURPOSE: To evaluate the efficacy and safety of CO2 Laser-assisted Sclerectomy Surgery (CLASS) in primary and pseudoexfoliative open-angle glaucoma. MATERIALS AND METHODS: Single-arm, open-label study included data from 9 medical centers located in 7 countries. Subjects underwent nonpenetrating CLASS procedure with a CO2 laser system (IOPtiMate). Intraocular pressure (IOP) and number of medications were measured at baseline, 1, 2, 4, and 6 weeks, and 3, 6, 12, 24, and 36 months. Complete success was defined as 5≤IOP≤18 mm Hg and at least 20% IOP reduction with no medications, and qualified success as the same with or without medications at 12, 24, and 36 months. RESULTS:A total of 111 consecutive eyes were enrolled in the study, 14 were excluded from the study due to protocol deviation or operator error. The mean age was 69.3±12.8 and 73.9% were whites. Percent change in IOP from baseline at 1, 2, and 3 years was, respectively, 45.1%, 46.8%, and 42.5% (P<0.001). Complete success rates after 12, 24, and 36 months were 60.2%, 57.9%, and 47.8%, respectively. Qualified success rates after 12, 24, and 36 months were 79.6%, 91.2%, and 84.8%, respectively. Number of medications dropped from 2.39±1.24 to 0.47±0.84, 0.53±0.75, and 0.71±0.89 at 12, 24, and 36 months, respectively (P<0.001). CONCLUSIONS: The CLASS procedure may be a simple and effective treatment for open-angle glaucoma providing extended relief of elevated IOP.
RCT Entities:
PURPOSE: To evaluate the efficacy and safety of CO2 Laser-assisted Sclerectomy Surgery (CLASS) in primary and pseudoexfoliative open-angle glaucoma. MATERIALS AND METHODS: Single-arm, open-label study included data from 9 medical centers located in 7 countries. Subjects underwent nonpenetrating CLASS procedure with a CO2 laser system (IOPtiMate). Intraocular pressure (IOP) and number of medications were measured at baseline, 1, 2, 4, and 6 weeks, and 3, 6, 12, 24, and 36 months. Complete success was defined as 5≤IOP≤18 mm Hg and at least 20% IOP reduction with no medications, and qualified success as the same with or without medications at 12, 24, and 36 months. RESULTS: A total of 111 consecutive eyes were enrolled in the study, 14 were excluded from the study due to protocol deviation or operator error. The mean age was 69.3±12.8 and 73.9% were whites. Percent change in IOP from baseline at 1, 2, and 3 years was, respectively, 45.1%, 46.8%, and 42.5% (P<0.001). Complete success rates after 12, 24, and 36 months were 60.2%, 57.9%, and 47.8%, respectively. Qualified success rates after 12, 24, and 36 months were 79.6%, 91.2%, and 84.8%, respectively. Number of medications dropped from 2.39±1.24 to 0.47±0.84, 0.53±0.75, and 0.71±0.89 at 12, 24, and 36 months, respectively (P<0.001). CONCLUSIONS: The CLASS procedure may be a simple and effective treatment for open-angle glaucoma providing extended relief of elevated IOP.