Publishing date: April 2021
Author(s): Thomas W Samuelson (1), Inder Paul Singh (2), Blake K Williamson (3), Heather Falvey (4), Won Chan Lee (5), Dawn Odom (6), David McSorley (6), L Jay Katz (4)
1 Minnesota Eye Consultants, Minneapolis, Minnesota, USA.
2 Eye Centers of Racine and Kenosha, Wisconsin, USA.
3 Williamson Eye Center, Baton Rouge, LA, USA.
4 Glaukos, San Clemente, CA, USA.
5 Econforte Consulting LLC, San Francisco, CA, USA.
6 RTI Health Solutions, Research Triangle Park, NC, USA.
OBJECTIVE: To assess QOL as measured by patient-reported outcomes (PRO) within the iStent inject pivotal trial.
DESIGN: Randomized controlled trial analysis of secondary outcomes.
METHODS: The Vision Function Questionnaire (VFQ-25) and Ocular Surface Disease Index (OSDI©) questionnaire were administered at baseline, months 1, 6, 12, and 24. PRO responders were defined as patients reaching improvement based on minimally important differences.
RESULTS: 505 patients were randomized (N = 386 iStent inject, N = 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 non-responders were medication free regardless of treatment group (P < .05).
CONCLUSIONS: 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.
Copyright © 2021. Published by Elsevier Inc.
Am J Ophthalmol. 2021 Mar 15;S0002-9394(21)00120-3. doi: 10.1016/j.ajo.2021.03.007. Online ahead of print.
Keywords: OSDI; PRO; QOL; VFQ-25; iStent inject; open angle glaucoma; patient-reported outcomes; vision-related quality of life
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