Dobson Velma, Quinn Graham E, Summers C Gail, Hardy Robert J, Tung Betty, Good William V
Arch Ophthalmol. 2011 Jul;129(7):840-6. doi: 10.1001/archophthalmol.2011.143.
To compare grating (resolution) visual acuity at 6 years of age in eyes that received early treatment (ET) for high-risk prethreshold retinopathy of prematurity (ROP) with that in eyes that underwent conventional management (CM).
In a randomized clinical trial, infants with bilateral, high-risk prethreshold ROP (n = 317) had one eye undergo ET and the other eye undergo CM, with treatment only if ROP progressed to threshold severity. For asymmetric cases (n = 84), the high-risk prethreshold eye was randomized to ET or CM.
Grating visual acuity measured at 6 years of age by masked testers using Teller acuity cards.
Monocular grating acuity results were obtained from 317 of 370 surviving children (85.6%). Analysis of grating acuity results for all study participants with high-risk prethreshold ROP showed no statistically significant overall benefit of ET (18.1% vs 22.8% unfavorable outcomes; P = .08). When the 6-year grating acuity results were analyzed according to a clinical algorithm (high-risk types 1 and 2 prethreshold ROP), a benefit was seen in type 1 eyes (16.4% vs 25.2%; P = .004) undergoing ET, but not in type 2 eyes (21.3% vs 15.9%; P = .29).
Early treatment of eyes with type 1 ROP improves grating acuity outcomes, but ET for eyes with type 2 ROP does not. APPLICATION TO CLINICAL MEDICINE: Type 1 eyes should be treated early; however, based on acuity results at 6 years of age, type 2 eyes should be cautiously monitored for progression to type 1 ROP. Trial Registration clinicaltrials.gov Identifier: NCT00027222.
比较接受早产高危阈值前视网膜病变(ROP)早期治疗(ET)的眼睛与接受传统治疗(CM)的眼睛在6岁时的光栅(分辨率)视力。
在一项随机临床试验中,患有双侧高危阈值前ROP的婴儿(n = 317)一只眼睛接受ET,另一只眼睛接受CM,仅在ROP进展到阈值严重程度时才进行治疗。对于不对称病例(n = 84),高危阈值前的眼睛随机分配接受ET或CM。
6岁时由蒙面测试人员使用泰勒视力卡片测量的光栅视力。
370名存活儿童中的317名(85.6%)获得了单眼光栅视力结果。对所有高危阈值前ROP研究参与者的光栅视力结果分析显示,ET没有统计学上的显著总体益处(不良结果分别为18.1%和22.8%;P = 0.08)。根据临床算法(高危1型和2型阈值前ROP)分析6岁时的光栅视力结果时,接受ET的1型眼睛有获益(分别为16.4%和25.2%;P = 0.004),但2型眼睛没有(分别为21.3%和15.9%;P = 0.