Parkinson Kevin M, Sayre Eric C, Tobe Sheldon W
, Coquitlam, Canada.
, Vancouver, Canada.
Int J Retina Vitreous. 2023 Jun 18;9(1):36. doi: 10.1186/s40942-023-00471-y.
To assess micro current to improve vision for dry age-related macular degeneration. Dry age-related macular degeneration is a major cause of blindness, disability, and severe erosion of quality of life, throughout the world. Beyond nutritional supplementation, there is no approved therapy.
This was a prospective randomized sham controlled clinical trial for participants with confirmed dry AMD with documented visual loss. Participants were randomized three to one, to receive transpalpebral external micro current electrical stimulation with the MacuMira device. The Treatment group received four treatments in the first two weeks, and two further treatments at weeks 14 and 26. Differences in BCVA and contrast sensitivity (CS) were estimated with mixed-effects repeated measures analysis of variance.
Change of visual acuity with ETDRS assessment of number of letters read (NLR) and contrast sensitivity at week 4 and 30, compared to the first visit, between 43 treatment and 19 sham control participants. The Sham Control group had NLR of 24.2 (SD 7.1) at baseline, 24.2 (SD 7.2) at 4 weeks, and 22.1 (SD7.4) at 30 weeks. The Treatment group had NLR of 19.6 (SD 8.9) at baseline, 27.6 (SD 9.1) at 4 weeks, and 27.8 (SD 8.4) at 30 weeks. The change in NLR from baseline in the Treatment compared to the Sham control group was 7.7 (95% CI 5.7, 9.7, p < 0.001) at 4 weeks and 10.4 (95% CI 7.8, 13.1, p < 0.001) at 30 weeks. There were similar benefits in CS.
This pilot study of transpalpebral microcurrent demonstrated improved visual measures and is very encouraging as a potential treatment for dry AMD.
NCT02540148, ClinicalTrials.gov.
评估微电流对改善干性年龄相关性黄斑变性患者视力的作用。干性年龄相关性黄斑变性是全球范围内导致失明、残疾以及生活质量严重下降的主要原因。除营养补充外，尚无获批的治疗方法。
这是一项针对确诊为干性年龄相关性黄斑变性且有视力下降记录的参与者进行的前瞻性随机假对照临床试验。参与者按3:1随机分组，接受使用MacuMira设备经睑部进行的外部微电流电刺激。治疗组在最初两周接受4次治疗，在第14周和第26周再接受2次治疗。采用混合效应重复测量方差分析评估最佳矫正视力（BCVA）和对比敏感度（CS）的差异。
在43名治疗组参与者和19名假对照组参与者中，与首次就诊相比，在第4周和第30周时通过早期糖尿病性视网膜病变研究（ETDRS）评估的视力表读数（NLR）变化以及对比敏感度情况。假对照组基线时NLR为24.2（标准差7.1），4周时为24.2（标准差7.2），30周时为22.1（标准差7.4）。治疗组基线时NLR为19.6（标准差8.9），4周时为27.6（标准差9.1），30周时为27.8（标准差8.4）。与假对照组相比，治疗组在第4周时NLR从基线的变化为7.7（95%置信区间5.7, 9.7, p < 0.001），在第30周时为10.4（95%置信区间7.8, 13.1, p < 0.001）。对比敏感度也有类似益处。
这项经睑部微电流的初步研究显示视力指标得到改善，作为干性年龄相关性黄斑变性的一种潜在治疗方法非常令人鼓舞。
NCT02540148，ClinicalTrials.gov。
