地理萎缩中的阅读表现：捕捉纵向变化的不同阅读速度测量方法的比较

IF 3.2 Q1 OPHTHALMOLOGY

Ophthalmology science Pub Date : 2024-12-30 DOI:10.1016/j.xops.2024.100700

Zhichao Wu BAppSc(Optom), PhD , Verena Steffen MSc , Will Harris MS , Catherine A. Cukras MD, PhD , Daniela Ferrara MD, PhD , Robyn H. Guymer MBBS, PhD

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引用次数: 0

摘要

目的比较不同的阅读速度测量方法对老年性黄斑变性继发性地理萎缩（GA）眼纵向视觉功能变化的影响。设计分析来自Chroma （NCT02247479）和Spectri （NCT02247531）的数据，这是两项设计相同的lampalizumab的III期、双盲、随机对照临床试验。参与者：940名年龄≥50岁的双侧GA患者，在1年随访期间，在≥3次就诊时完成单眼阅读速度测试。方法采用明尼苏达低视力阅读测验（MNRead）评估单目阅读速度。推导并比较了四种不同的阅读速度指标：最快句子的阅读速度（RS1）、最快3个句子的平均阅读速度（RS2）、大于关键印刷尺寸的句子的平均阅读速度（RS3）和最大10个印刷尺寸的平均阅读速度（称为阅读可及性指数[ACC]）。主要结果测量值变异系数（CV），较低的值反映了相对于个体间变异性的纵向变化的测量效果较好。结果所有4项阅读速度测量在48、72和96周时均较基线显著下降(P <；0.001)。ACC和RS2的cv（分别为204%和208%）低于RS1 (255%；P≤0.002)和RS3 (224%；P≥0.068)，但两项指标间差异无统计学意义（P = 0.362）。所有4项阅读速度测量与眼底自体荧光成像GA面积从基线到48周的变化之间也有统计学意义，但弱负相关(ρ = - 0.13至- 0.15；所有P <；0.001)。结论从日常生活中发现的10个印刷尺寸（ACC）或最快的3句阅读（RS2）得出的平均阅读速度在捕捉GA眼功能进步性下降方面优于2种广泛使用的测量方法（RS1和RS3），可能是未来临床试验和研究的首选测量方法。随着时间的推移，所有阅读速度测量也显示出预期的渐进式下降，但它们只显示出与GA增长的弱相关性。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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Reading Performance in Geographic Atrophy: Comparison of Different Reading Speed Measures for Capturing Longitudinal Changes

Purpose

To compare different reading speed measures for capturing longitudinal visual function changes in eyes with geographic atrophy (GA) secondary to age-related macular degeneration.

Design

Analysis of data from Chroma (NCT02247479) and Spectri (NCT02247531), 2 identically designed, phase III, double-masked, randomized controlled clinical trials for lampalizumab.

Participants

Nine hundred forty participants aged ≥50 years old with bilateral GA, who completed monocular testing of reading speed at ≥3 visits over >1-year follow-up.

Methods

Monocular reading speed was assessed using the Minnesota Low-Vision Reading Test (MNRead). Four different reading speed measures were derived and compared: reading speed of the fastest sentence read (RS₁), mean reading speed of the 3 fastest sentences read (RS₂), mean reading speed of the sentences larger than the critical print size (RS₃), and mean reading speed of the 10 largest print sizes (termed the Reading Accessibility Index [ACC]).

Main Outcome Measures

Coefficient of variation (CV), with lower values reflecting better performance of a measure for capturing longitudinal change relative to interindividual variability.

Results

All 4 reading speed measures showed a significant decline at 48, 72, and 96 weeks from baseline (P < 0.001 for all). The CVs for ACC and RS₂ (204% and 208%, respectively) were lower than for RS₁ (255%; P ≤ 0.002) and RS₃ (224%; P ≥ 0.068) for detecting change from baseline at 48 weeks, but these 2 measures were not significantly different from each other (P = 0.362). There were also statistically significant, but weak, negative correlations between the change from baseline at 48 weeks for all 4 reading speed measures with GA area on fundus autofluorescence imaging (ρ = −0.13 to −0.15; all P < 0.001).

Conclusions

The mean reading speed derived from either the 10 print sizes found in everyday life (ACC) or the fastest 3 sentences read (RS₂) was better than 2 widely used measures (RS₁ and RS₃) at capturing progressive functional decline in eyes with GA and may be the preferred measures in future clinical trials and studies. All reading speed measures also showed an expected progressive decline over time, but they only showed a weak correlation with GA growth.