Min Seung Hyun, Chen Shijia, Xu Jinling, Chen Bingzhen, Chen Hui, Wang Yuwen, Zhou Jiawei, Yu Xudong
School of Ophthalmology and Optometry and Eye Hospital, State Key Laboratory of Ophthalmology, Optometry and Vision Science, Wenzhou Medical University, Wenzhou, China.
Department of Ophthalmology and Visual Sciences, McGill Vision Research, McGill University, Montreal, QC, Canada.
Front Neurosci. 2021 Apr 9;15:622729. doi: 10.3389/fnins.2021.622729. eCollection 2021.
Recently, Eyetronix Flicker Glass (EFG) has been introduced as a novel treatment for amblyopia. It alternatively deprives the visual input of each eye rapidly (e.g., 7 Hz). However, whether it is comparable with standard patching therapy is unclear. In this randomized clinical trial, we evaluate the efficacy of an EFG therapy as treatment for amblyopia in children and compare it to the patching therapy.
We tested 31 children (aged 4-13 years) with amblyopia. They were assigned into one of the two treatment groups and were treated for 12 weeks. The first group was treated with EFG for 1 h/day (Flicker Group) and the latter with a standard patch (Patching Group) for 2 h/day. We designated changes from baseline in best-corrected visual acuity (BCVA) of the amblyopic eye as our primary outcome. Changes from baseline in other visual outcomes, such as contrast sensitivity, stereopsis, and fusional vergence range were measured as secondary outcome.
BCVA improved significantly at 12 weeks relative to baseline in both the Flicker (0.13 ± 0.11 logMAR; mean ± SD) and Patching Groups (0.21 ± 0.14 logMAR). However, the improvements were not significantly different between groups ( = 0.13). Contrast sensitivity also significantly improved at 3 and 12 cycles/degree between baseline and 12 weeks in both groups ('s < 0.05). However, stereopsis and fusion range did not improve significantly in both groups.
An EFG therapy and patching improved BCVA similarly for children with amblyopia at 12 weeks. Both therapies improved the contrast sensitivity at 3 and 12 cycles per degree (cpd); however, only patching improved the contrast sensitivity at 6 cpd. Both therapies did not benefit binocular visual functions (stereopsis and fusional vergence range). We believe that EFG can be an additional choice for therapy.
chictr.org number: ChiCTR2000034436.
最近，Eyetronix闪烁眼镜（EFG）已被引入作为弱视的一种新治疗方法。它交替快速剥夺每只眼睛的视觉输入（例如，7赫兹）。然而，它是否与标准遮盖疗法相当尚不清楚。在这项随机临床试验中，我们评估了EFG疗法作为儿童弱视治疗方法的疗效，并将其与遮盖疗法进行比较。
我们测试了31名患有弱视的儿童（年龄4 - 13岁）。他们被分配到两个治疗组之一，并接受12周的治疗。第一组每天使用EFG治疗1小时（闪烁组），另一组每天使用标准眼罩（遮盖组）治疗2小时。我们将弱视眼最佳矫正视力（BCVA）相对于基线的变化指定为主要结局。将其他视觉结局相对于基线的变化，如对比敏感度、立体视和融合性聚散范围作为次要结局进行测量。
在闪烁组（0.13±0.11对数最小分辨角；平均值±标准差）和遮盖组（0.21±0.14对数最小分辨角）中，12周时BCVA相对于基线均有显著改善。然而，两组之间的改善没有显著差异（P = 0.13）。两组在基线和12周之间，对比敏感度在3和12周/度时也有显著改善（P值<0.05）。然而，两组的立体视和融合范围均未显著改善。
对于弱视儿童，EFG疗法和遮盖疗法在12周时对BCVA的改善相似。两种疗法在3和12周/度时均改善了对比敏感度；然而，只有遮盖疗法在6周/度时改善了对比敏感度。两种疗法对双眼视觉功能（立体视和融合性聚散范围）均无益处。我们认为EFG可以作为一种额外的治疗选择。
中国临床试验注册中心编号：ChiCTR2000034436 。
