Objective The Aurolab aqueous drainage implant (AADI) has the potential advantages of less encapsulation and greater cost-effectiveness than the Ahmed glaucoma valve (AGV). The aim of this study was to compare the surgical success and outcomes of the AADI compared to the AGV in Middle-Eastern children. Methods A comparative retrospective study of consecutive paediatric patients in a tertiary eye hospital was undertaken. Data collected included demographics, type of glaucoma, intraocular pressure (IOP), number of anti-glaucoma medications (AGMs) and any subsequent complications or further surgeries. Analysis The mean IOP, number of AGMs, surgical success and number of reoperations was compared for the two groups. Surgical success at each visit was defined as IOP of ≥6 mm Hg and ≤21 mm Hg or if the reduction of IOP was ≥20% reduced from baseline. Results A total of 126 tube surgeries (56 eyes in AADI and 70 eyes in AGV) were performed in patients aged ≤18 years from 2014 to 2019. No difference was observed in the mean IOP between the two groups except at the first month post-operative visit. After six months, the AADI group had a consistently significant lower mean number of AGMs. At last follow-up, 21 (37.5%) eyes in the AADI group were glaucoma medication-free vs 15 (21.4%) eyes in the AGV group (pp=0.047). Kaplan-Meier analysis showed equivalent cumulative probability of success at two years of 69.9% [(45.9%–84.9%)] for AADI vs 66.8% [(53.4%–77.1%])) for the AGV, respectively. Twenty-four eyes in the AGV group needed one or more subsequent surgeries, whereas 13 eyes needed one or more surgery in the AADI group. Conclusions This study shows an acceptable safety profile for the AADI in children, with a rate of failure that is comparable to the AGV, but less need for glaucoma re-operation or glaucoma medication in the first post-postoperative year. Data are available upon reasonable request. Data are available at reasonable request by contacting the IRB Department: IRB@kkesh.med.sa

中文翻译：

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Aurolab 房水引流植入物 (AADI) 与 Ahmed 青光眼瓣膜治疗中东儿童难治性小儿青光眼的手术效果

目的 Aurolab 房水引流植入物 (AADI) 具有比 Ahmed 青光眼阀 (AGV) 更少的封装和更高的成本效益的潜在优势。本研究的目的是比较 AADI 与 AGV 在中东儿童中的手术成功率和结果。方法对一家三级眼科医院的连续儿科患者进行比较回顾性研究。收集的数据包括人口统计、青光眼类型、眼压 (IOP)、抗青光眼药物 (AGM) 的数量以及任何后续并发症或进一步手术。分析 比较两组的平均眼压、AGM 次数、手术成功率和再手术次数。每次就诊的手术成功定义为眼压≥6 mm Hg 且≤21 mm Hg，或者眼压降低比基线降低≥20%。结果 2014-2019年≤18岁患者共进行了126例管状手术（AADI 56眼，AGV 70眼）。除术后1个月外，两组平均眼压无差异。手术访问。六个月后，AADI 组的 AGM 平均数持续显着降低。末次随访时，AADI 组 21 只（37.5%）眼无青光眼药物治疗，而 AGV 组 15 只（21.4%）只眼（pp=0.047）。Kaplan-Meier 分析显示，两年内 AADI 的等效累积成功概率分别为 69.9% [(45.9%–84.9%)] 和 66.8% [(53.4%–77.1%]))。AGV 组有 24 只眼需要进行一次或多次后续手术，而 AADI 组有 13 只眼需要进行一次或多次手术。结论 本研究显示儿童 AADI 的安全性可接受，其失败率与 AGV 相当，但术后第一年对青光眼再次手术或青光眼药物的需求较少。可根据合理要求提供数据。可通过联系 IRB 部门的合理要求获得数据：IRB@kkesh.med.sa