晚期原发性闭角型青光眼伴白内障的虹膜切开术与虹膜角膜切除术:随机非劣效性试验

IF 3.7 3区 医学 Q1 OPHTHALMOLOGY
Yunhe Song , Fengbin Lin , Aiguo Lv , Yao Zhang , Lan Lu , Lin Xie , Guangxian Tang , Huiping Yuan , Yangfan Yang , Jiangang Xu , Ping Lu , Meichun Xiao , Xiaomin Zhu , Xiaowei Yan , Wulian Song , Xiaoyan Li , Hengli Zhang , Fei Li , Zhenyu Wang , Ling Jin , Xiulan Zhang
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引用次数: 0

摘要

目的研究晚期原发性闭角型青光眼(PACG)和白内障患者接受虹膜切开术(PVP)与虹膜乳突切除术(PVP)的有效性和安全性。方法共招募了124例晚期PACG和白内障患者(124只眼),其中虹膜切开术组65例,虹膜乳突切除术组59例。对患者进行了为期 12 个月的随访,并进行了标准化评估。主要结果是眼压(IOP)从基线到术后12个月的降低幅度,其中非劣效差为4毫米汞柱。结果12个月后,在降低眼压方面,虹膜开孔术的效果不优于虹膜前囊切除术,与约40毫米汞柱的基线值相比,平均眼压分别降低了-26.1毫米汞柱和-25.7毫米汞柱(P = 0.383)。两组患者术后使用药物的平均数量都有明显减少(P < 0.001)。两组的累积成功率相当(P = 0.890)。不过,与咽喉切除术(分别为 23.7% 和 20.3%)相比,咽喉切开术的术后并发症和干预率较低(分别为 12.3% 和 4.6%)。相胃管切开术组的手术时间更短(22.1 ± 6.5 分钟 vs. 38.8 ± 11.1 分钟;P = 0.030),12 个月后的生活质量(EQ-5D-5 L)改善率更高(7.0 ± 11.5 vs. 3.0 ± 12.9,P = 0.030)。结论就降低晚期 PACG 和白内障的眼压而言,相控阵开颅术的效果并不优于相控阵蟹状切除术。此外,相控开孔术的手术时间更短、术后并发症发生率更低、术后干预更少、术后生活质量更高。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma with cataract: A randomized non-inferiority trial

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.

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来源期刊
CiteScore
8.10
自引率
18.20%
发文量
197
审稿时长
6 weeks
期刊介绍: The Asia-Pacific Journal of Ophthalmology, a bimonthly, peer-reviewed online scientific publication, is an official publication of the Asia-Pacific Academy of Ophthalmology (APAO), a supranational organization which is committed to research, training, learning, publication and knowledge and skill transfers in ophthalmology and visual sciences. The Asia-Pacific Journal of Ophthalmology welcomes review articles on currently hot topics, original, previously unpublished manuscripts describing clinical investigations, clinical observations and clinically relevant laboratory investigations, as well as .perspectives containing personal viewpoints on topics with broad interests. Editorials are published by invitation only. Case reports are generally not considered. The Asia-Pacific Journal of Ophthalmology covers 16 subspecialties and is freely circulated among individual members of the APAO’s member societies, which amounts to a potential readership of over 50,000.
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