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前瞻性随机对照研究 Aurolab 水性引流植入物与 Ahmed 青光眼阀治疗难治性青光眼:一项初步研究。

A prospective randomized controlled study of Aurolab aqueous drainage implant versus Ahmed glaucoma valve in refractory glaucoma: A pilot study.

机构信息

Advanced Eye Center, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Indian J Ophthalmol. 2018 Nov;66(11):1580-1585. doi: 10.4103/ijo.IJO_427_18.

DOI:10.4103/ijo.IJO_427_18
PMID:30355865
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6213703/
Abstract

PURPOSE

To study the efficacy of the Aurolab aqueous drainage implant (AADI) compared to Ahmed glaucoma valve (AGV) in patients with refractory glaucoma.

METHODS

This was a prospective, randomized controlled trial. Thirty-eight adult patients (>18 years) scheduled for a glaucoma drainage device (GDD) were randomized into two groups to receive either AGV or AADI. Primary outcome measures: intraocular pressure (IOP) control and requirement of antiglaucoma medications; secondary outcome measures: final best correct visual acuity (log MAR), visual field (Visual field index [VFI], mean deviation [MD] and pattern standard deviation [PSD]), postoperative complications and additional interventions. Complete success was defined as IOP ≥5-≤18 mmHg without antiglaucoma medications/laser/additional glaucoma surgery or any vision threatening complications.

RESULTS

There were 19 age and sex-matched patients in each group. Both groups had comparable IOP before surgery (P = 0.61). The AGV group had significantly lower IOP compared to AADI group (7.05 ± 4.22 mmHg vs 17.90 ± 10.32 mmHg, P = <0.001) at 1 week. The mean postoperative IOP at 6 months was not significantly different in the two groups (13.3 ± 4.2 and 11.4 ± 6.8 mmHg respectively; P = 0.48). At 6 months, complete success rate according to antiglaucoma medication criteria was 78.94% in AADI and 47.36% in AGV groups. AGV group required 1.83 times more number of topical medications than AADI group. There was no significant difference in early (P = 0.75) and late (P = 0.71) postoperative complications in the AADI and AGV group. The complete success rate was higher in AADI group (68.42%) than AGV group (26.31%) (P = 0.034).

CONCLUSION

In this study, AADI appears to have comparable efficacy versus AGV implant with higher complete success rate at 6 months follow-up.

摘要

目的

研究金葡素眼内引流植入物(AADI)与 Ahmed 青光眼阀(AGV)在难治性青光眼患者中的疗效比较。

方法

这是一项前瞻性、随机对照试验。38 例成年(>18 岁)患者计划接受青光眼引流装置(GDD)治疗,随机分为两组,分别接受 AGV 或 AADI 治疗。主要观察指标:眼压(IOP)控制和抗青光眼药物的需求;次要观察指标:最终最佳矫正视力(logMAR)、视野(视野指数[VFI]、平均偏差[MD]和模式标准差[PSD])、术后并发症和额外干预。完全成功定义为 IOP≥5-≤18mmHg,无需抗青光眼药物/激光/额外青光眼手术或任何威胁视力的并发症。

结果

两组各有 19 例年龄和性别匹配的患者。两组患者术前的 IOP 无显著差异(P=0.61)。AGV 组的 IOP 显著低于 AADI 组(术后 1 周时分别为 7.05±4.22mmHg 和 17.90±10.32mmHg,P<0.001)。两组患者术后 6 个月的平均 IOP 无显著差异(分别为 13.3±4.2mmHg 和 11.4±6.8mmHg;P=0.48)。根据抗青光眼药物标准,术后 6 个月时,AADI 组的完全成功率为 78.94%,AGV 组为 47.36%。AGV 组需要的局部药物数量比 AADI 组多 1.83 倍。AADI 组和 AGV 组的早期(P=0.75)和晚期(P=0.71)术后并发症无显著差异。AADI 组的完全成功率(68.42%)高于 AGV 组(26.31%)(P=0.034)。

结论

在这项研究中,AADI 与 AGV 植入物的疗效相当,但在 6 个月的随访中,其完全成功率更高。

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The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes.
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Pediatric Glaucoma-From Screening, Early Detection to Management.小儿青光眼——从筛查、早期发现到治疗
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