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艾哈迈德青光眼阀植入术:1年随访后无移植短隧道小瓣与巩膜补片移植的比较:一项随机临床试验

Ahmed Glaucoma Valve Implantation: Graft-Free Short Tunnel Small Flap versus Scleral Patch Graft after 1-Year Follow-up: A Randomized Clinical Trial.

作者信息

Pakravan Mohammad, Hatami Mohammadmehdi, Esfandiari Hamed, Yazdani Shahin, Doozandeh Azadeh, Samaeili Azadeh, Kheiri Bahareh, Conner Ian

机构信息

Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Ophthalmol Glaucoma. 2018 Nov-Dec;1(3):206-212. doi: 10.1016/j.ogla.2018.10.008. Epub 2018 Oct 25.

Abstract

PURPOSE

To compare the efficacy and safety of the graft-free short tunnel small flap (STSF) technique with that of the scleral patch graft (SPG) in Ahmed glaucoma valve (AGV) (New World Medical Inc, Rancho Cucamonga, CA) implantation.

DESIGN

Randomized clinical trial.

PARTICIPANTS

A total of 203 eyes of 203 patients with medically uncontrolled glaucoma, including 102 in the STSF group and 101 in the SPG group.

METHODS

Patients were enrolled and assigned randomly to STSF or SPG.

MAIN OUTCOME MEASURES

Tube exposure, intraocular pressure (IOP), number of glaucoma medications, best-corrected visual acuity, surgical complications, and success rate (defined as IOP >5 mmHg, ≤21 mmHg, and IOP reduction ≥20% from baseline at 2 consecutive visits after 3 months, no reoperation for glaucoma).

RESULTS

Only 1 patient in the SPG group developed tube exposure at 1-year follow-up. The cumulative probability of success during the first year of follow-up was 70% in the STSF group and 65% in the SPG group (P = 0.36). The IOP decreased significantly from 29.6±8.6 mmHg at baseline to 16.4±3.6 mmHg at the final follow-up in the STSF group (P = 0.001). The corresponding numbers for the SPG group were 30.9±11.2 and 15.8±4.7, respectively (P = 0.001). The final IOP was comparable between both groups (P = 0.65). Mean ± standard deviation of the number of glaucoma medications was 1.8±0.9 in the STSF group and 1.6±0.9 in the SPG group at final follow-up (P = 0.32). Postoperative complications developed in 8 patients (19%) in the STSF group and 9 patients (23%) in the SPG group (P = 0.81).

CONCLUSIONS

The STSF and SPG techniques had a comparable complication rate at the 1-year follow-up. Both techniques were comparable in terms of success rate, postoperative IOP, and glaucoma medications.

摘要

目的

比较无移植片短隧道小瓣(STSF)技术与巩膜补片移植(SPG)技术在植入艾哈迈德青光眼引流阀(AGV,新世界医疗公司,加利福尼亚州兰乔库卡蒙加)时的疗效和安全性。

设计

随机临床试验。

参与者

203例药物治疗无法控制的青光眼患者的203只眼,其中STSF组102只眼,SPG组101只眼。

方法

招募患者并随机分配至STSF组或SPG组。

主要观察指标

引流管外露情况、眼压(IOP)、青光眼药物使用数量、最佳矫正视力、手术并发症及成功率(定义为眼压>5 mmHg且≤21 mmHg,且在3个月后的连续2次随访中眼压较基线降低≥20%,无需再次进行青光眼手术)。

结果

在1年随访期,SPG组仅1例患者出现引流管外露。随访第1年,STSF组的累积成功率为70%,SPG组为65%(P = 0.36)。STSF组眼压从基线时的29.6±8.6 mmHg显著降至最终随访时的16.4±3.6 mmHg(P = 0.001)。SPG组相应数值分别为30.9±11.2和15.8±4.7(P = 0.001)。两组最终眼压相当(P = 0.65)。最终随访时,STSF组青光眼药物使用数量的均值±标准差为1.8±0.9,SPG组为1.6±0.9(P = 0.32)。STSF组8例患者(19%)出现术后并发症,SPG组9例患者(23%)出现术后并发症(P = 0.81)。

结论

在1年随访期,STSF技术和SPG技术的并发症发生率相当。两种技术在成功率、术后眼压及青光眼药物使用方面相当。

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