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Phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma with cataract: A randomized non-inferiority trial

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机构: [1]State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou 510060, China [2]Handan City Eye Hospital (The Third Hospital of Handan), Handan 056001, China [3]Department of Ophthalmology, West China Hospital of Sichuan University, Chengdu, Sichuan Province 610041, China [4]Department of Ophthalmology, Fujian Medical University Union Hospital, Fuzhou, Fujian Province 350001, China [5]Department of Ophthalmology, the Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China [6]Department of Ophthalmology, Shijiazhuang People’s Hospital, Hebei Province, 050000, China [7]Department of Ophthalmology, the 2nd Affiliated Hospital, Harbin Medical University, Harbin, Heilongjiang 150086, China [8]Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China [9]Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China j [10]Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region of China [11]NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, London, UK [12]Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Republic of Korea [13]Singapore National Eye Centre, Singapore Eye Research Institute, Singapore, Singapore [14]Hamilton Glaucoma Center, Viterbi Family Department of Ophthalmology, Shiley Eye Institute, University of California, San Diego, CA, USA [15]The International Eye Research Institute, the Chinese University of Hong Kong (Shenzhen), Shenzhen, China
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关键词: Primary angle-closure glaucoma Cataract Phacotrabeculectomy Minimally invasive glaucoma surgery Randomized controlled trial

摘要:
To investigate the effectiveness and safety of phacogoniotomy versus phacotrabeculectomy (PVP) among patients with advanced primary angle-closure glaucoma (PACG) and cataracts.Multicenter, randomized controlled, non-inferiority trial.A total of 124 patients (124 eyes) with advanced PACG and cataracts were enrolled, with 65 in the phacogoniotomy group and 59 in the phacotrabeculectomy group. Patients were followed up for 12 months with standardized evaluations. The primary outcome was the reduction in intraocular pressure (IOP) from baseline to 12 months postoperatively, of which a non-inferiority margin of 4 mmHg was evaluated. Secondary outcomes included the cumulative surgical success rate, postoperative complications, and changes in the number of glaucoma medications.After 12 months, phacogoniotomy demonstrated non-inferiority to phacotrabeculectomy in terms of IOP reduction, with mean IOP reductions of - 26.1 mmHg and - 25.7 mmHg (P = 0.383), respectively, from baseline values of around 40 mmHg. Both groups experienced a significant reduction in the mean number of medications used postoperatively (P < 0.001). The cumulative success rate was comparable between the groups (P = 0.890). However, phacogoniotomy had a lower rate of postoperative complications and interventions (12.3% and 4.6%) compared to phacotrabeculectomy (23.7% and 20.3% respectively). The phacogoniotomy group reported shorter surgery time (22.1 ± 6.5 vs. 38.8 ± 11.1 min; P = 0.030) and higher quality of life (EQ-5D-5 L) improvement at 12 months (7.0 ± 11.5 vs. 3.0 ± 12.9, P = 0.010) than the phacotrabeculectomy group.Phacogoniotomy was non-inferior to phacotrabeculectomy in terms of IOP reduction for advanced PACG and cataracts. Additionally, phacogoniotomy provided a shorter surgical time, lower postoperative complication rate, fewer postoperative interventions, and better postoperative quality of life.Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.

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出版当年[2023]版:
大类 | 3 区 医学
小类 | 2 区 眼科学
最新[2023]版:
大类 | 3 区 医学
小类 | 2 区 眼科学
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Q1 OPHTHALMOLOGY
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Q1 OPHTHALMOLOGY

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第一作者机构: [1]State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou 510060, China
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