医学
随机对照试验
青光眼
眼压
眼科
外科
临床试验
内科学
开角型青光眼
超声乳化术
作者
Fengbin Lin,Yunhe Song,Hengli Zhang,Sujie Fan,Meichun Xiao,Xiaomin Zhu,Xiaowei Yan,Xiaoyan Li,Wulian Song,Li Tang,Tingli Wen,Guangxian Tang,Huiping Yuan,Yangfan Yang,Jiangang Xu,Xin Zhan,Minwen Zhou,Xiaohuan Zhao,Fei Li,Zefeng Yang
标识
DOI:10.1016/j.apjo.2026.100353
摘要
PURPOSE: To evaluate the 3-year efficacy and safety of phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma (PACG) with cataract. DESIGN: Multicenter, randomized controlled, open-label, non-inferiority trial. METHODS: Patients were randomized 1:1 to undergo either phacogoniotomy (65 eyes) or phacotrabeculectomy (59 eyes). Three years retention was 92.3% (60/65) and 83.1% (49/59) for each group, respectively. Primary outcome was 3-year intraocular pressure (IOP) reduction (noninferiority margin: 4 mmHg). Secondary outcomes included surgical success, complications, hypotensive medications used; additional outcomes were changes in visual acuity (BCVA), visual field (VF), and corneal endothelial cell density (ECD). RESULTS: At 3 years, phacogoniotomy reduced mean IOP from 40.2 (10.3) to 14.1 (2.4) mmHg (-26.1 [10.4] mmHg reduction); phacotrabeculectomy, from 39.7 (9.3) to 14.4 (2.5) mmHg (-25.3 [9.2] mmHg reduction). Adjusted between-group difference in IOP change was -0.37 mmHg (95% CI, -1.32-0.58 mmHg; P = 0.44), meeting noninferiority. Complete (78.3% vs 89.8%; P = 0.13) and qualified (90.0% vs 91.8%; P > 0.999) success rates were comparable. Hypotensive medications declined in both groups (phacogoniotomy: 2.1 [1.2] to 0.2 [0.6]; phacotrabeculectomy: 2.1 [1.3] to 0.0 [0.2]; P = 0.06 for 3-year difference). BCVA improvements (0.1 vs 0.0 logMAR; P = 0.49), VF stability (MD difference:1.42 dB, P = 0.26; PSD difference: 0.22 dB, P = 0.75), and ECD loss (difference: 2%; P = 0.53) were similar. No new complications occurred in extended follow-up. CONCLUSIONS: At 3 years, phacogoniotomy remained non-inferior to phacotrabeculectomy in IOP reduction for advanced PACG with cataract.
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