超声乳化白内障吸除术联合房角分离术与小梁切除术治疗白内障合并原发性闭角型青光眼的随机非劣效性临床试验。

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

机构信息

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.

Handan City Eye Hospital (The Third Hospital of Handan), Handan 056001, China.

出版信息

Asia Pac J Ophthalmol (Phila). 2024 Jan-Feb;13(1):100033. doi: 10.1016/j.apjo.2023.100033. Epub 2023 Dec 26.

DOI:10.1016/j.apjo.2023.100033

PMID:38383075

Abstract

PURPOSE

To investigate the effectiveness and safety of phacogoniotomy versus phacotrabeculectomy (PVP) among patients with advanced primary angle-closure glaucoma (PACG) and cataracts.

DESIGN

Multicenter, randomized controlled, non-inferiority trial.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

探讨超声睫状体成形术（PG）与超声睫状体光凝术联合小梁切除术（PVP）治疗原发性闭角型青光眼（PACG）合并白内障的有效性和安全性。

设计

多中心、随机、对照、非劣效性临床试验。

方法

纳入 124 例（124 只眼）PACG 合并白内障患者，其中 65 例患者接受 PG 治疗（PG 组），59 例患者接受 PVP 治疗（PVP 组）。两组患者均接受 12 个月的随访，随访期间行标准化评估。主要结局为术后 12 个月时眼压（IOP）较基线值的降低程度，评估非劣效性界值为 4mmHg。次要结局包括累积手术成功率、术后并发症及降眼压药物使用数量的变化。

结果

术后 12 个月时，PG 组的 IOP 降低程度与 PVP 组相似，平均 IOP 降幅分别为-26.1mmHg 和-25.7mmHg（P=0.383），两组患者基线 IOP 均约为 40mmHg。两组患者术后均显著减少了降眼压药物的使用数量（P<0.001）。两组累积手术成功率相当（P=0.890）。但 PG 组术后并发症及干预的发生率低于 PVP 组（分别为 12.3%和 4.6%比 23.7%和 20.3%）。PG 组的手术时间更短（22.1±6.5min 比 38.8±11.1min；P=0.030），术后 12 个月时生活质量（EQ-5D-5L）改善评分更高（7.0±11.5 比 3.0±12.9，P=0.010）。