Evaluating Time in Range for Visual Acuity and Macular Thickness as Outcome Measures for Randomized Clinical Trials.

IF 2.7 3区医学 Q2 OPHTHALMOLOGY

Translational Vision Science & Technology Pub Date : 2026-08-03 DOI:10.1167/tvst.15.8.12

Igor Kozak, Meet Panjwani, Robert Wu, Jonathan M Holmes

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引用次数: 0

Abstract

Purpose: To compare performance of time in range (TIR) with other traditional longitudinal outcome measures (change from baseline and area under the curve [AUC] for change).

Methods: We used data from DRCR.net Randomized Clinical Trials (Protocol T, I and AC) for diabetic macular edema, with outcomes of visual acuity (VA) and optical coherence tomography (OCT) central subfield thickness (CST). Outcomes were calculated at one year, stratified by baseline VA (0-39, 40-59, 60-69, and ≥70 letters score). TIR-VA was defined as proportion of time with VA above threshold (64, 69, 74, 79, and 84), and TIR-CST as proportion of time with CST equal or less than threshold (250, 300, 350, and 400 µm). Performance was assessed based on effect size.

Results: In Protocol T, TIR-VA had largest effect size when baseline VA was poor: TIR-VA 69 (0.655), AUC-VA (0.607), and change VA (0.557). When baseline VA was moderate and good, TIR-VA effect sizes were similar to AUC-VA and change-VA. When baseline VA was excellent, effect size was largest for TIR-VA 74 versus AUC-VA or change-VA (0.199 vs. 0.179 vs. 0.083). For CST outcomes, TIR-CST was similar to or better than AUC-CST and change-CST across most baseline VA strata. In Protocols I and AC, TIR outcomes also had similar or larger effect size than AUC and change.

Conclusions: TIR-VA and TIR-CST performed well across baseline VA strata and across RCTs.

Translational relevance: TIR-VA and TIR-CST may be complementary outcome measures for future RCTs.

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评估视力和黄斑厚度范围内的时间作为随机临床试验的结果指标。

目的：比较时间范围（TIR）与其他传统的纵向结局指标（基线变化和曲线下面积[AUC]变化）的表现。方法：我们使用DRCR.net随机临床试验（方案T， I和AC）的数据，用于糖尿病性黄斑水肿，包括视力（VA）和光学相干断层扫描（OCT）中心亚场厚度（CST）。结果在一年内计算，按基线VA（0-39、40-59、60-69和≥70字母评分）分层。TIR-VA定义为VA高于阈值（64、69、74、79和84）的时间比例，而TIR-CST定义为CST等于或小于阈值（250、300、350和400µm）的时间比例。根据效应大小评估绩效。结果：在方案T中，基线VA较差时，TIR-VA的效应量最大：TIR-VA 69 (0.655), AUC-VA(0.607)，变化VA（0.557）。当基线VA为中等和良好时，TIR-VA效应大小与AUC-VA和change-VA相似。当基线VA良好时，TIR-VA 74与AUC-VA或change-VA的效应量最大（0.199 vs. 0.179 vs. 0.083）。对于CST结果，在大多数基线VA地层中，TIR-CST与AUC-CST和change-CST相似或更好。在方案I和AC中，TIR结果也具有与AUC和变化相似或更大的效应量。结论：TIR-VA和TIR-CST在基线VA层和rct中表现良好。翻译相关性：TIR-VA和TIR-CST可能是未来随机对照试验的补充结果测量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Translational Vision Science & Technology Engineering-Biomedical Engineering

CiteScore

5.70

自引率

3.30%

发文量

346

审稿时长

25 weeks

期刊介绍： Translational Vision Science & Technology (TVST), an official journal of the Association for Research in Vision and Ophthalmology (ARVO), an international organization whose purpose is to advance research worldwide into understanding the visual system and preventing, treating and curing its disorders, is an online, open access, peer-reviewed journal emphasizing multidisciplinary research that bridges the gap between basic research and clinical care. A highly qualified and diverse group of Associate Editors and Editorial Board Members is led by Editor-in-Chief Marco Zarbin, MD, PhD, FARVO. The journal covers a broad spectrum of work, including but not limited to: Applications of stem cell technology for regenerative medicine, Development of new animal models of human diseases, Tissue bioengineering, Chemical engineering to improve virus-based gene delivery, Nanotechnology for drug delivery, Design and synthesis of artificial extracellular matrices, Development of a true microsurgical operating environment, Refining data analysis algorithms to improve in vivo imaging technology, Results of Phase 1 clinical trials, Reverse translational ("bedside to bench") research. TVST seeks manuscripts from scientists and clinicians with diverse backgrounds ranging from basic chemistry to ophthalmic surgery that will advance or change the way we understand and/or treat vision-threatening diseases. TVST encourages the use of color, multimedia, hyperlinks, program code and other digital enhancements.