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=0.1) with a mean of 3.4±0.7 glaucoma medications (p=0.35) 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=0.6) and number of glaucoma medications (1.1±1 in the PGI group versus 1.6±1.03 in the AGV group, p=0.1). The success rate of PGI was 80% vs. 73.6% in the AGV (p=0.2). 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.

中文翻译：

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难治性儿童青光眼 Paul Ahmed 比较 （PAC） 研究的初步结果。


目的 比较 Paul 青光眼植入物 （PGI） 与 Ahmed 青光眼瓣膜 （AGV） 在治疗难治性儿童青光眼方面的有效性和安全性。设计 随机对照试验。地点 两个临床中心。方法 一项正在进行的随机对照试验，包括 ≤18 岁的难治性儿童青光眼患者，他们计划进行青光眼引流植入手术。患者被随机分配接受 PGI 或 AGV。主要结局是眼压 （IOP） 降低。次要结局包括青光眼药物减少、成功率和并发症发生率。成功率定义为在没有或使用青光眼药物（最多三种局部青光眼药物）的情况下达到 6-21 mmHg 的术后眼压，无需额外的青光眼手术，也没有发生威胁视力的并发症或疾病进展的证据。使用口服青光眼药物，如乙酰唑胺，被认为是失败的。结果 目前的报告包括 44 名完成术后一年随访的患者 （44 只眼） （PGI 组 25 名，AGV 组 19 名）。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±6.1 mmHg，平均青光眼药物为 3.6±0.6，而 AGV 组为 29.8±6.1 mmHg （p=0.1），平均青光眼药物为 3.4±0.7 （p=0.35）。一年时，平均眼压 （PGI 组为 14.9±4.1 mmHg，AGV 组为 15.5±3.5，p=0.6）和青光眼药物数量 （PGI 组为 1.1±1 vs 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 的成功率为 73.6% （p=0.2）。两组术后并发症发生率相当 （每组 3 只眼）。结论/相关性 术后 1 年，两组之间的 IOP 降低、青光眼药物减少、成功率和并发症发生率相当。