原发性闭角型青光眼的24个月前瞻性随机比较：外穿小梁成形术与小梁切除术。

IF 3.7 3区医学 Q1 OPHTHALMOLOGY

Asia-Pacific Journal of Ophthalmology Pub Date : 2025-05-01 DOI:10.1016/j.apjo.2025.100167

Wenqing Ye , Shaodan Zhang , Shuqing Zhu , Jinxin Li , Juan Gu , Mian Zhao , Kaiting Jiang , Yanqian Xie , Rongrong Le , Weihe Zhou , Clement C. Tham , Mingguang He , Yuanbo Liang , Ningli Wang

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引用次数: 0

摘要

目的：比较外穿小梁成形术与小梁切除术治疗原发性闭角型青光眼24个月的疗效和安全性。方法：这是一项前瞻性、随机对照试验。我们招募了患有PACG和眼压控制不充分的患者。纳入的患者随机分为外穿性小管成形术组（PCP组）和小梁切除术组（TRAB组）。主要观察指标为眼压（IOP）、青光眼用药次数、成功率和眼表疾病指数（OSDI）问卷。手术成功（定义1）定义为6mm Hg≤IOP≤21mm Hg且IOP降低≥20%，不使用青光眼药物（完全成功）或不使用青光眼药物（合格成功）。结果：共入组52只眼（44例），PCP组25只眼，TRAB组27只眼。PCP组（85.0%）与TRAB组（83.3%）在24个月意向治疗（ITT）分析中定义1的合格成功率相似（P=1.000）。在每个方案（PP）分析中，定义1的合格成功率在PCP组为81.3%，在TRAB组为83.3% （P = 0.972）。但PCP组术后IOP≤15mm Hg的成功率低于TRAB组，IOP降低≥20%，ITT分析完全成功（PCP 35.0% vs TRAB 65.2%, P = 0.048）， PP分析合格成功（PCP 31.3% vs TRAB 69.6%, P = 0.025）。PCP组（11.9±8.5）和TRAB组（16.6±14.3）平均OSDI评分相等（P = 0.302）。PCP组和TRAB组的主要并发症为低压相关并发症（24.0% vs 33.3%, P = 0.458）。结论：与小梁切除术相比，外穿小梁成形术在24个月时具有相似的成功率和相似的并发症。如果没有频繁的水泡干预，穿透性导管成形术可能是一种很有前途的手术，特别是对于早期或轻度PACG患者。

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24-month prospective randomized comparison of ab externo penetrating canaloplasty versus trabeculectomy in primary angle-closure glaucoma

Purpose

To report the 24-month efficacy and safety of ab externo penetrating canaloplasty compared with trabeculectomy in the treatment of primary angle-closure glaucoma (PACG).

Methods

This is a prospective, randomized, controlled trial. Patients with PACG and inadequately controlled intraocular pressure (IOP) were recruited. Patients enrolled were randomized to either ab externo penetrating canaloplasty (PCP group) or trabeculectomy (TRAB group). The main outcome measures were intraocular pressure (IOP), number of glaucoma medications, success rate and ocular surface disease index (OSDI) questionnaire. Surgical success (definition 1) was defined as 6 mm Hg ≤ IOP ≤ 21 mm Hg with an IOP reduction of ≥ 20 % without glaucoma medications (complete success) or regardless of glaucoma medications (qualified success).

Results

A total of 52 eyes (44 patients) were finally enrolled with 25 eyes in PCP group and 27 eyes in TRAB group. PCP group (85.0 %) had a similar qualified success rate compared with TRAB group (87.0 %) with definition 1 at 24 months in intention to treat (ITT) analysis (P = 1.000). In per protocol (PP) analysis, the qualified success with definition 1 were 81.3 % in PCP group and 87.0 % in TRAB group (P = 0.972). But PCP group had a lower success rate in postoperative IOP ≤ 15 mm Hg with an IOP reduction of ≥ 20 % than in TRAB group, in ITT analysis with complete success (PCP 35.0 % vs TRAB 65.2 %, P = 0.048) and PP analysis with qualified success (PCP 31.3 % vs. TRAB 69.6 %, P = 0.025). The mean OSDI score was equal in PCP group (11.9 ± 8.5) and TRAB group (16.6 ± 14.3) (P = 0.302). Hypotony-associated complications were the main complications in PCP group and TRAB group (24.0 % vs. 33.3 %, P = 0.458).

Conclusions

Compared with trabeculectomy, ab externo penetrating canaloplasty had a similar qualified success rate and comparable complications at 24 months. Without frequent bleb interventions, penetrating canaloplasty may be a promising surgery for PACG patients especially with early or mild stages.

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来源期刊

Asia-Pacific Journal of Ophthalmology OPHTHALMOLOGY-

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.