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一项用于双眼弱视治疗的对比增量方案的随机临床试验。

A randomized clinical trial of contrast increment protocols for binocular amblyopia treatment.

机构信息

Retina Foundation of the Southwest, Dallas, Texas.

Retina Foundation of the Southwest, Dallas, Texas.

出版信息

J AAPOS. 2020 Oct;24(5):282.e1-282.e7. doi: 10.1016/j.jaapos.2020.06.009. Epub 2020 Oct 9.

DOI:10.1016/j.jaapos.2020.06.009
PMID:33045374
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8328197/
Abstract

BACKGROUND

Most clinical trials of contrast-rebalanced binocular amblyopia treatment used a contrast increment protocol of 10% daily with successful play. Paired with a definition of success requiring only 15-30 min/day of gameplay, this increment protocol could allow children to reach 100% fellow eye contrast in 3-9 hours; however, this may not provide adequate therapeutic time with reduced fellow eye contrast. The purpose of this study was to compare the original protocol against three alternative contrast increment protocols designed to increase the number of treatment hours.

METHODS

In this prospective study, 63 amblyopic children (4-10 years; amblyopic eye visual acuity, 20/40-125) were randomly assigned one of four daily contrast increment protocols for 4 weeks, all starting with 20% fellow eye contrast: 10%, 5%, 0%, or 10% for first 4 weeks then reset to 20% and repeat 10% increment for the final 4 weeks. Children played contrast-rebalanced games for 1 hour/day, 5 days/week. Best-corrected visual acuity, stereoacuity, and suppression were assessed at baseline and every 2 weeks until the 8-week outcome visit.

RESULTS

At baseline, mean amblyopic eye best-corrected visual acuity was 0.47 ± 0.14 logMAR (20/60), improving overall 0.14 ± 0.08 logMAR (1.4 lines; P < 0.0001) at 8 weeks. All four protocols resulted in similar improvement in visual acuity (0.13-0.16 logMAR; all Ps < 0.0002). Stereoacuity and suppression also improved (all Ps < 0.05).

CONCLUSIONS

None of the new protocols resulted in less improvement than the original 10% contrast increment protocol. Contrast-rebalanced binocular games yielded significant improvements in visual acuity, stereoacuity, and suppression with or without daily contrast increments.

摘要

背景

大多数对比平衡双眼弱视治疗的临床试验都采用 10%的每日对比度递增方案,且取得了成功。与仅需每天玩游戏 15-30 分钟即可成功的定义相结合,该递增方案可以使儿童在 3-9 小时内达到 100%的同眼对比度;然而,这可能无法提供足够的治疗时间,因为同眼对比度降低。本研究的目的是比较原始方案与三个旨在增加治疗时间的替代对比度递增方案。

方法

在这项前瞻性研究中,63 名弱视儿童(4-10 岁;弱视眼视力,20/40-125)被随机分配到四种每日对比度递增方案中的一种,持续 4 周,所有方案均从 20%的同眼对比度开始:10%、5%、0%或 10%,前 4 周递增,然后重置为 20%,最后 4 周再递增 10%。儿童每天玩 1 小时的对比度平衡游戏,每周 5 天。在基线和每 2 周评估最佳矫正视力、立体视锐度和抑制情况,直到 8 周的结果访问。

结果

在基线时,平均弱视眼最佳矫正视力为 0.47±0.14 logMAR(20/60),8 周时总体提高 0.14±0.08 logMAR(1.4 行;P<0.0001)。所有四个方案的视力都有类似的提高(0.13-0.16 logMAR;所有 P<0.0002)。立体视锐度和抑制也有所提高(所有 P<0.05)。

结论

新方案均未导致改善程度低于原始 10%对比度递增方案。对比度平衡双眼游戏可显著提高视力、立体视锐度和抑制,无论是否每天增加对比度。

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