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白内障超声乳化吸除联合内镜睫状体光凝术与单纯白内障超声乳化吸除术治疗原发性闭角型青光眼的初步随机对照试验

Combined Phacoemulsification-Endoscopic Cyclophotocoagulation versus Phacoemulsification Alone in Primary Angle-Closure Glaucoma: A Pilot Randomized Controlled Trial.

作者信息

Lai Isabel S W, Chan Noel C Y, Ling Anni, Baig Nafees B, Chan Poemen P, Wang Yu Meng, Tham Clement C

机构信息

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China; Hong Kong Eye Hospital, Kowloon, Hong Kong SAR, China.

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China; Prince of Wales Hospital, Shatin, Hong Kong SAR, China.

出版信息

Ophthalmol Glaucoma. 2021 Nov-Dec;4(6):589-596. doi: 10.1016/j.ogla.2021.03.007. Epub 2021 Mar 13.

Abstract

PURPOSE

To compare combined phacoemulsification plus endoscopic cyclophotocoagulation (ECP) versus phacoemulsification alone in primary angle-closure glaucoma (PACG) with coexisting cataract.

DESIGN

Prospective randomized controlled clinical trial-a pilot study.

PARTICIPANTS

Forty-eight PACG eyes of 48 patients with coexisting cataract.

INTERVENTION

Recruited patients were randomized into undergoing phacoemulsification plus ECP or phacoemulsification alone. After surgery, patients were followed up every 3 months for 2 years.

MAIN OUTCOME MEASURES

Intraocular pressure (IOP) and requirement for topical glaucoma drugs.

RESULTS

Twenty-seven PACG eyes were randomized to receive combined phacoemulsification plus ECP, and 21 PACG eyes underwent phacoemulsification alone. There was no statistically significant difference in mean preoperative IOP between combined phacoemulsification plus ECP and phacoemulsification groups (20.0 mmHg vs. 20.7 mmHg; P = 0.71). Phacoemulsification plus ECP resulted in lower mean postoperative IOP than phacoemulsification alone at all follow-up visits, but the differences only reached statistical significance at 1 month (P = 0.01), 12 months (P = 0.01), and 24 months (P = 0.04) postoperatively. There was no statistically significant difference in mean preoperative number of topical glaucoma drugs between combined phacoemulsification plus ECP and phacoemulsification groups (3.3 vs 3.1, P = 0.71). Combined phacoemulsification plus ECP resulted in lower glaucoma drug requirement than phacoemulsification alone at all follow-up visits, but the differences did not reach statistical significance at any time points postoperatively (P ≥ 0.05). Both groups were comparable in visual improvement, complication rate, need for additional surgical intervention, and visual field changes.

CONCLUSIONS

Combined phacoemulsification plus ECP is noninferior to phacoemulsification alone in controlling IOP in PACG eyes with cataract. Combined phacoemulsification plus ECP resulted in lower mean IOP and glaucoma drug requirement than phacoemulsification alone at all follow-up visits in this pilot study, but the differences did not reach statistical significance at the majority of time points. A large-scale randomized controlled trial is in progress to evaluate these differences.

摘要

目的

比较白内障合并原发性闭角型青光眼(PACG)患者行白内障超声乳化吸除联合内镜睫状体光凝术(ECP)与单纯白内障超声乳化吸除术的效果。

设计

前瞻性随机对照临床试验——一项初步研究。

研究对象

48例合并白内障的PACG患者的48只患眼。

干预措施

将入选患者随机分为白内障超声乳化吸除联合ECP组或单纯白内障超声乳化吸除组。术后每3个月随访1次,共随访2年。

主要观察指标

眼压(IOP)及局部使用青光眼药物的需求。

结果

27只PACG患眼被随机分配接受白内障超声乳化吸除联合ECP,21只PACG患眼接受单纯白内障超声乳化吸除。白内障超声乳化吸除联合ECP组与单纯白内障超声乳化吸除组术前平均IOP无统计学差异(20.0 mmHg对20.7 mmHg;P = 0.71)。在所有随访中,白内障超声乳化吸除联合ECP术后平均IOP均低于单纯白内障超声乳化吸除术,但差异仅在术后1个月(P = 0.01)、12个月(P = 0.01)和24个月(P = 0.04)时具有统计学意义。白内障超声乳化吸除联合ECP组与单纯白内障超声乳化吸除组术前局部使用青光眼药物的平均数量无统计学差异(3.3对3.1,P = 0.71)。在所有随访中,白内障超声乳化吸除联合ECP组对青光眼药物的需求均低于单纯白内障超声乳化吸除组,但术后各时间点差异均无统计学意义(P≥0.05)。两组在视力改善、并发症发生率、额外手术干预需求和视野变化方面具有可比性。

结论

在控制白内障合并PACG患眼的眼压方面,白内障超声乳化吸除联合ECP不劣于单纯白内障超声乳化吸除术。在本初步研究中,白内障超声乳化吸除联合ECP在所有随访中导致的平均IOP和青光眼药物需求均低于单纯白内障超声乳化吸除术,但在大多数时间点差异无统计学意义。一项大规模随机对照试验正在进行,以评估这些差异。

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