Rahat Husain1,2, Tan Do3, Jimmy Lai4, Naris Kitnarong5, Monisha E Nongpiur1, Shamira A Perera1,2, Ching L Ho1,2, Sheng K Lim6, Tin Aung1,2. 1. Singapore National Eye Centre, Singapore Eye Research Institute, Singapore. 2. Yong Loo Lin School of Medicine, National University of Singapore, Singapore. 3. Vietnam National Institute of Ophthalmology, Hanoi, Vietnam. 4. Li Ka Shing Faculty of Medicine, University of Hong Kong and Queen Mary's Hospital, Hong Kong. 5. Faculty of Medicine, Siriraj Hospital, Mahjidol University, Bangkok, Thailand. 6. Department of Ophthalmology, Guy's and St Thomas' National Health Services Foundation Trust, London, United Kingdom.
Abstract
IMPORTANCE: The effectiveness of intraocular pressure (IOP) lowering phacoemulsification combined with goniosynechialysis (GSL) compared with phacoemulsification without GSL remains unknown. OBJECTIVE: To compare the IOP outcome after 1 year in patients with synechial primary angle-closure disease (PACD) and cataract who underwent phacoemulsification with intraocular lens implantation (PEI) alone compared with PEI with GSL (PEI-GSL). DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized clinical trial was conducted from September 29, 2011, to March 16, 2015; data analysis was performed from April 1, 2015, to March 4, 2019. Patients with PACD, defined as primary angle closure or primary angle-closure glaucoma, and at least 90° peripheral anterior synechiae (PAS) with cataract were included. Patients were randomized to undergo PEI alone or PEI-GSL. Patients were followed up for 1 year with standardized evaluations. Intention-to-treat analysis was performed. INTERVENTIONS: Phacoemulsification with intraocular lens implantation alone or with GSL. MAIN OUTCOMES AND MEASURES: Successful control of IOP at 12 months, defined as IOP 21 mm Hg or lower without use of topical IOP-lowering medications and a decrease in IOP of 20% or more from baseline IOP. RESULTS: Data from 78 patients (78 eyes) were analyzed. Of these, 37 patients were Chinese (47.4%) and 54 were women (69.2%); mean (SD) age was 67.7 (8.9) years. Mean deviation (SD) at baseline was -13.5 dB (9.4 dB). Forty patients were randomized to the PEI group and 38 to the PEI-GSL group. The mean (SD) IOP at baseline was 22.3 (8.5) mm Hg for the PEI group and 22.9 (5.3) mm Hg for the PEI-GSL group. At 1 year, the mean IOP was 14.3 (5.0) mm Hg for the PEI group and 15.9 (4.5) mm Hg for the PEI-GSL group. Successful control at 1 year occurred in 21 patients (52.5%) in the PEI group and 22 patients (57.9%) in the PEI-GSL group (mean difference, 5.4%; 95% CI, -18.0% to 28.2%; P = .63). In eyes that achieved successful control, mean IOP at 1 year was 12.5 (2.7) mm Hg (range, 7.0-19.0) for the PEI group and 13.6 (2.4) mm Hg (range, 9.0-18.0) for the PEI-GSL group. The number of medications at baseline and 1 year decreased from a mean of 2.2 (0.8) to 0.5 (0.9) in the PEI group and 1.9 (0.9) to 0.6 (1.2) in the PEI-GSL group (P < .001 for each), with a mean change difference of 0.4% (95% CI, -0.02% to 0.9%; P = .06). There were 3 postoperative complications (7.5%) in the PEI group and 3 (7.9%) in the PEI-GSL group. These included IOP spike (IOP≥30 mm Hg) (n = 3), excessive anterior chamber inflammation (n = 1), and posterior capsule opacification (n = 2). CONCLUSIONS AND RELEVANCE: This randomized clinical trial was unable to show that PEI-GSL added additional IOP lowering compared with PEI alone in patients with PACD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02376725.
IMPORTANCE: The effectiveness of intraocular pressure (IOP) lowering phacoemulsification combined with goniosynechialysis (GSL) compared with phacoemulsification without GSL remains unknown. OBJECTIVE: To compare the IOP outcome after 1 year in patients with synechial primary angle-closure disease (PACD) and cataract who underwent phacoemulsification with intraocular lens implantation (PEI) alone compared with PEI with GSL (PEI-GSL). DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized clinical trial was conducted from September 29, 2011, to March 16, 2015; data analysis was performed from April 1, 2015, to March 4, 2019. Patients with PACD, defined as primary angle closure or primary angle-closure glaucoma, and at least 90° peripheral anterior synechiae (PAS) with cataract were included. Patients were randomized to undergo PEI alone or PEI-GSL. Patients were followed up for 1 year with standardized evaluations. Intention-to-treat analysis was performed. INTERVENTIONS: Phacoemulsification with intraocular lens implantation alone or with GSL. MAIN OUTCOMES AND MEASURES: Successful control of IOP at 12 months, defined as IOP 21 mm Hg or lower without use of topical IOP-lowering medications and a decrease in IOP of 20% or more from baseline IOP. RESULTS: Data from 78 patients (78 eyes) were analyzed. Of these, 37 patients were Chinese (47.4%) and 54 were women (69.2%); mean (SD) age was 67.7 (8.9) years. Mean deviation (SD) at baseline was -13.5 dB (9.4 dB). Forty patients were randomized to the PEI group and 38 to the PEI-GSL group. The mean (SD) IOP at baseline was 22.3 (8.5) mm Hg for the PEI group and 22.9 (5.3) mm Hg for the PEI-GSL group. At 1 year, the mean IOP was 14.3 (5.0) mm Hg for the PEI group and 15.9 (4.5) mm Hg for the PEI-GSL group. Successful control at 1 year occurred in 21 patients (52.5%) in the PEI group and 22 patients (57.9%) in the PEI-GSL group (mean difference, 5.4%; 95% CI, -18.0% to 28.2%; P = .63). In eyes that achieved successful control, mean IOP at 1 year was 12.5 (2.7) mm Hg (range, 7.0-19.0) for the PEI group and 13.6 (2.4) mm Hg (range, 9.0-18.0) for the PEI-GSL group. The number of medications at baseline and 1 year decreased from a mean of 2.2 (0.8) to 0.5 (0.9) in the PEI group and 1.9 (0.9) to 0.6 (1.2) in the PEI-GSL group (P < .001 for each), with a mean change difference of 0.4% (95% CI, -0.02% to 0.9%; P = .06). There were 3 postoperative complications (7.5%) in the PEI group and 3 (7.9%) in the PEI-GSL group. These included IOP spike (IOP≥30 mm Hg) (n = 3), excessive anterior chamber inflammation (n = 1), and posterior capsule opacification (n = 2). CONCLUSIONS AND RELEVANCE: This randomized clinical trial was unable to show that PEI-GSL added additional IOP lowering compared with PEI alone in patients with PACD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02376725.