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经巩膜睫状体平坦部内路房水引流管植入术与房角镜辅助经巩膜隧道小梁切开术治疗开角型青光眼的随机对照研究。

Ab interno canaloplasty versus gonioscopy-assisted transluminal trabeculotomy in open-angle glaucoma: a randomised controlled trial.

机构信息

Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Institute of Ophthalmology, Capital Medical University, Beijing, China.

Ophthalmology, University of California San Francisco, San Francisco, California, USA.

出版信息

Br J Ophthalmol. 2024 May 21;108(5):687-694. doi: 10.1136/bjo-2022-323163.

Abstract

OBJECTIVE

To compare the efficacy and safety of ab interno canaloplasty (ABiC) with gonioscopy-assisted transluminal trabeculotomy (GATT) in patients with open-angle glaucoma (OAG).

METHOD

This randomised clinical trial recruited eyes with OAG and no previous incisional ocular surgery, among which 38 were randomised to ABiC and 39 to GATT. Follow-ups were performed at 1, 3, 6 and 12 months postoperatively. The primary outcome measures were intraocular pressure (IOP) and use of glaucoma medication at 12 months postoperatively. The secondary outcome measure was complete surgical success (not requiring glaucoma surgery, IOP ≤21 mm Hg and non-use of glaucoma medications).

RESULTS

Both groups had similar demographic and ocular characteristics. A total of 71 of the 77 subjects (92.2%) completed 12-month follow-up. At 12 months, mean IOP was 19.0±5.2 mm Hg in the ABiC group and 16.0±3.1 mm Hg in the GATT group (p=0.003). Overall, 57.2% of ABiC patients and 77.8% of GATT patients were medication free (p=0.06). The number of glaucoma medications was 0.9±1.3 in the ABiC group and 0.6±1.2 in the GATT group (p=0.27). The 12-month cumulative rate of complete surgical success was 56% in the ABiC group and 75% in the GATT group (p=0.09). Three eyes in the ABiC group and one eye in the GATT group required additional glaucoma surgery. Hyphema (87% vs 47%) and supraciliary effusion (92% vs 71%) were noted more often in the GATT group than in the ABiC group.

CONCLUSIONS

The preliminary result showed that GATT had an advantage over ABiC in IOP reduction for OAG patients, accompanied by favourable safety at 12-month postoperatively.

TRIAL REGISTRATION NUMBER

ChiCTR1800016933.

摘要

目的

比较内路房角成形术(ABiC)与房角镜辅助经巩膜小梁切开术(GATT)治疗开角型青光眼(OAG)的疗效和安全性。

方法

这是一项随机临床试验,纳入了无既往切口性眼外科手术的 OAG 患者,其中 38 例患者随机分配至 ABiC 组,39 例患者分配至 GATT 组。术后 1、3、6 和 12 个月进行随访。主要观察指标为术后 12 个月时的眼压(IOP)和青光眼药物使用情况。次要观察指标为完全手术成功率(无需再次青光眼手术、IOP≤21mmHg 和未使用青光眼药物)。

结果

两组患者的人口统计学和眼部特征相似。共有 77 例受试者中的 71 例(92.2%)完成了 12 个月的随访。术后 12 个月时,ABiC 组的平均 IOP 为 19.0±5.2mmHg,GATT 组为 16.0±3.1mmHg(p=0.003)。总体而言,ABiC 组有 57.2%的患者无需药物治疗,GATT 组有 77.8%的患者无需药物治疗(p=0.06)。ABiC 组的青光眼药物数量为 0.9±1.3 种,GATT 组为 0.6±1.2 种(p=0.27)。ABiC 组的 12 个月完全手术成功率为 56%,GATT 组为 75%(p=0.09)。ABiC 组有 3 只眼和 GATT 组有 1 只眼需要进行额外的青光眼手术。ABiC 组的前房积血(87%比 47%)和睫状体上腔积液(92%比 71%)发生率高于 GATT 组。

结论

初步结果显示,与 ABiC 相比,GATT 更有利于 OAG 患者的眼压降低,并且在术后 12 个月时具有良好的安全性。

临床试验注册号

ChiCTR1800016933。

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