Initial Results of the Paul Ahmed Comparison (PAC) Study in Refractory Childhood Glaucoma

IF 4.1 1区医学 Q1 OPHTHALMOLOGY

American Journal of Ophthalmology Pub Date : 2024-11-05 DOI:10.1016/j.ajo.2024.10.024

ABDELRAHMAN M. ELHUSSEINY , OMAR M. KHALED , MUHAMMAD Z. CHAUHAN , MOHAMED S. SAYED , TAREK SHAARAWY

{"title":"Initial Results of the Paul Ahmed Comparison (PAC) Study in Refractory Childhood Glaucoma","authors":"ABDELRAHMAN M. ELHUSSEINY , OMAR M. KHALED , MUHAMMAD Z. CHAUHAN , MOHAMED S. SAYED , TAREK SHAARAWY","doi":"10.1016/j.ajo.2024.10.024","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>To compare the effectiveness and safety of the Paul glaucoma implant (PGI) to the Ahmed glaucoma valve (AGV) in managing refractory childhood glaucoma.</div></div><div><h3>Design</h3><div>Randomized controlled trial.</div></div><div><h3>Setting</h3><div>Two clinical centers.</div></div><div><h3>Methods</h3><div>An ongoing randomized controlled trial including patients ≤ 18 years with refractory childhood glaucoma in whom glaucoma drainage implant surgery was planned. Patients were randomized to receive either PGI or AGV. The primary outcome was the intraocular pressure (IOP) reduction. Secondary outcomes included glaucoma medication reduction, success rate, and complications rate. The success rate was defined as achieving a postoperative IOP between 6-21 mmHg without or with glaucoma medications (up to three topical glaucoma medications), without the need for additional glaucoma surgeries, and without the occurrence of vision-threatening complications or evidence of disease progression. The use of oral glaucoma medications, such as acetazolamide, was considered a failure.</div></div><div><h3>Results</h3><div>The current report included 44 patients (44 eyes) who completed the one-year postoperative follow-up (25 in the PGI group versus 19 in the AGV group). The mean age at the time of surgery was 96.9 ± 59.1 months (90.5 ± 60.04 months in the PGI group and 105.4 ± 58.5 months in the AGV group). Preoperatively, the mean IOP was 32.6 ± 6.1 mmHg with a mean of 3.6 ± 0.6 glaucoma medications in the PGI group, compared with 29.8 ± 6.1 mmHg (<em>P</em> = .1) with a mean of 3.4 ± 0.7 glaucoma medications (<em>P</em> = .35) in the AGV group. At one year, there were no statistically significant differences in the mean IOP (14.9 ± 4.1 mmHg in the PGI group versus 15.5 ± 3.5 in the AGV group, <em>P</em> = .6) and number of glaucoma medications (1.1 ± 1 in the PGI group versus 1.6 ± 1.03 in the AGV group, <em>P</em> = .1). The success rate of PGI was 80% versus 73.6% in the AGV (<em>P</em> = .2). The postoperative complications rate was comparable in both groups (three eyes in each group).</div></div><div><h3>Conclusion/Relevance</h3><div>At one year postoperatively, the IOP reduction, reduction of glaucoma medications, success rates, and rate of complications were comparable between both groups.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"271 ","pages":"Pages 71-78"},"PeriodicalIF":4.1000,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002939424005051","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Purpose

To compare the effectiveness and safety of the Paul glaucoma implant (PGI) to the Ahmed glaucoma valve (AGV) in managing refractory childhood glaucoma.

Design

Randomized controlled trial.

Setting

Two clinical centers.

Methods

An ongoing randomized controlled trial including patients ≤ 18 years with refractory childhood glaucoma in whom glaucoma drainage implant surgery was planned. Patients were randomized to receive either PGI or AGV. The primary outcome was the intraocular pressure (IOP) reduction. Secondary outcomes included glaucoma medication reduction, success rate, and complications rate. The success rate was defined as achieving a postoperative IOP between 6-21 mmHg without or with glaucoma medications (up to three topical glaucoma medications), without the need for additional glaucoma surgeries, and without the occurrence of vision-threatening complications or evidence of disease progression. The use of oral glaucoma medications, such as acetazolamide, was considered a failure.

Results

The current report included 44 patients (44 eyes) who completed the one-year postoperative follow-up (25 in the PGI group versus 19 in the AGV group). The mean age at the time of surgery was 96.9 ± 59.1 months (90.5 ± 60.04 months in the PGI group and 105.4 ± 58.5 months in the AGV group). Preoperatively, the mean IOP was 32.6 ± 6.1 mmHg with a mean of 3.6 ± 0.6 glaucoma medications in the PGI group, compared with 29.8 ± 6.1 mmHg (P = .1) with a mean of 3.4 ± 0.7 glaucoma medications (P = .35) in the AGV group. At one year, there were no statistically significant differences in the mean IOP (14.9 ± 4.1 mmHg in the PGI group versus 15.5 ± 3.5 in the AGV group, P = .6) and number of glaucoma medications (1.1 ± 1 in the PGI group versus 1.6 ± 1.03 in the AGV group, P = .1). The success rate of PGI was 80% versus 73.6% in the AGV (P = .2). The postoperative complications rate was comparable in both groups (three eyes in each group).

Conclusion/Relevance

At one year postoperatively, the IOP reduction, reduction of glaucoma medications, success rates, and rate of complications were comparable between both groups.

查看原文本刊更多论文

难治性儿童青光眼保罗-艾哈迈德比较（PAC）研究的初步结果。

目的：比较保罗青光眼植入器（PGI）和艾哈迈德青光眼瓣膜（AGV）治疗难治性儿童青光眼的有效性和安全性：随机对照试验：方法：正在进行的随机对照试验：方法：一项正在进行的随机对照试验，包括计划接受青光眼引流植入手术的18岁以下难治性儿童青光眼患者。患者被随机分配接受 PGI 或 AGV。主要结果是眼压降低。次要结果包括青光眼药物减少量、成功率和并发症发生率。成功率的定义是在不使用或使用青光眼药物（最多三种局部青光眼药物）的情况下，术后眼压达到 6-21 mmHg，无需进行额外的青光眼手术，并且没有出现危及视力的并发症或疾病进展的迹象。使用乙酰唑胺等口服青光眼药物被视为失败：本报告包括完成术后一年随访的 44 名患者（44 只眼）（PGI 组 25 人，AGV 组 19 人）。手术时的平均年龄为（96.9±59.1）个月（PGI 组为（90.5±60.04）个月，AGV 组为（105.4±58.5）个月）。术前，PGI 组的平均眼压为 32.6±6.1mmHg，平均服用青光眼药物 3.6±0.6，而 AGV 组为 29.8±6.1mmHg（P=0.1），平均服用青光眼药物 3.4±0.7（P=0.35）。一年后，平均眼压（PGI 组为 14.9±4.1 mmHg，AGV 组为 15.5±3.5，P=0.6）和青光眼用药次数（PGI 组为 1.1±1，AGV 组为 1.6±1.03，P=0.1）差异无统计学意义。PGI的成功率为80%，而AGV为73.6%（P=0.2）。两组的术后并发症发生率相当（每组 3 眼）：术后一年，两组患者的眼压降低率、青光眼药物用量减少率、成功率和并发症发生率相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

American Journal of Ophthalmology 医学-眼科学

CiteScore

9.20

自引率

7.10%

发文量

406

审稿时长

36 days

期刊介绍： The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the American Journal of Ophthalmology and supplementary material are also presented online at www.AJO.com and on ScienceDirect. The American Journal of Ophthalmology publishes Full-Length Articles, Perspectives, Editorials, Correspondences, Books Reports and Announcements. Brief Reports and Case Reports are no longer published. We recommend submitting Brief Reports and Case Reports to our companion publication, the American Journal of Ophthalmology Case Reports. Manuscripts are accepted with the understanding that they have not been and will not be published elsewhere substantially in any format, and that there are no ethical problems with the content or data collection. Authors may be requested to produce the data upon which the manuscript is based and to answer expeditiously any questions about the manuscript or its authors.