From Minnesota Eye Consultants, Minneapolis, Minnesota, USA (T.W.S).
Eye Centers of Racine and Kenosha, Racine, Wisconsin, USA (I.P.S.).
Am J Ophthalmol. 2021 Sep;229:220-229. doi: 10.1016/j.ajo.2021.03.007. Epub 2021 Mar 15.
To assess quality of life (QOL) as measured by patient-reported outcomes (PRO) within the iStent inject® pivotal trial.
Randomized controlled trial analysis of secondary outcomes.
The Vision Function Questionnaire (VFQ-25) and Ocular Surface Disease Index (OSDI) questionnaire were administered at baseline and at months 1, 6, 12, and 24. PRO responders were defined as patients reaching improvement based on minimally important differences.
A total of 505 patients were randomized (386 iStent inject® [Glaukos], 119 surgery alone). The iStent inject® group exhibited a greater percentage of PRO responders across all follow-up visits over 24 months, averaging 58.0% vs 45.8%; P < .05 for VFQ-25 composite scores and 56.7% vs 48.9%; P < .05 for OSDI composite scores. Odds of being a responder in the iStent inject® group was 60% (P < .05) higher for the VFQ-25 and 32% (P > .05) higher for the ODSI. Driving (49.0% vs 28.8%; P < .05), ocular pain (59.3% vs 47.2%; P < .05), and general vision (71.8% vs 60.0%; P < .05) were the VFQ-25 subscales responsible for differences between treatment groups. At month 24, 76.5% of VFQ-25 responders and 62.5% of nonresponders were medication free regardless of treatment group (P < .05).
Exploratory analysis suggests that by reducing medication dependence, implantation with the micro-scale iStent inject® device with cataract surgery may improve QOL vs cataract surgery alone over 24 months, with improvements influenced by ocular symptoms and vision-related activities.
评估 iStent inject® 主要试验中通过患者报告结果（PRO）测量的生活质量（QOL）。
二次结局随机对照试验分析。
在基线和第 1、6、12 和 24 个月时，使用视力功能问卷（VFQ-25）和眼表面疾病指数（OSDI）问卷进行评估。PRO 应答者定义为根据最小重要差异达到改善的患者。
共 505 例患者随机分组（386 例 iStent inject®[Glaukos]，119 例单纯手术）。在 24 个月的所有随访中，iStent inject®组显示出更高比例的 PRO 应答者，平均分别为 58.0%和 45.8%；VFQ-25 综合评分 P <.05，分别为 56.7%和 48.9%；OSDI 综合评分 P <.05。iStent inject®组在 VFQ-25 应答者的可能性高 60%（P <.05），在 ODSI 应答者的可能性高 32%（P >.05）。在 iStent inject®组中，驾驶（49.0% vs 28.8%；P <.05）、眼痛（59.3% vs 47.2%；P <.05）和一般视力（71.8% vs 60.0%；P <.05）是治疗组之间差异的 VFQ-25 子量表。在第 24 个月时，76.5%的 VFQ-25 应答者和 62.5%的非应答者无论治疗组如何均无需药物治疗（P <.05）。
探索性分析表明，与单纯白内障手术相比，通过减少对药物的依赖，植入微尺度 iStent inject® 设备与白内障手术联合使用可能在 24 个月内提高生活质量，改善受眼部症状和与视力相关的活动影响。
