Eye Hospital, D-45879 Gelsenkirchen, Germany.
Restor Neurol Neurosci. 2013;31(5):571-8. doi: 10.3233/RNN-130322.
To evaluate the effect of transpalpebral electrotherapy on patients with dry age-related macular degeneration (AMD).
22 patients were randomized in two groups to either receive therapy (n = 12) or placebo (n = 10). There was no statistically significant difference for age and initial visual acuity (VA) between the two groups (p = 0.6; ANOVA). Treatment was performed on 5 consecutive days. On each day two sessions were applied. Every session included 8 spots (40 sec/spot) around the eye globe. The current applied (changing frequency 5-80 Hz) varied individually between 150 and 220 μA. Patients were examined before treatment, at the end of the 5-day treatment period, after 4 weeks and at 6 months. Examinations included a standardized VA testing, using ETDRS letters, contrast sensitivity, macular sensitivity and fixation stability using microperimetry and measurements with SD-OCT.
At the end of week 1, mean VA improved markedly (p = 0.001; T test), with 7 out of 12 patients showing an improvement of more than 5 letters. After 4 weeks, there was an improvement of more than 10 letters in 3 patients (mean + 5.7 letters; p = 0.001; T test) whereas at 6 months a loss of 1.6 letters was observed. Only 4 (33%) of our patients did not show any improvement at all. Contrast sensitivity displayed a similar pattern. Within one week after treatment, there was a rapid improvement (+4.4 optotypes; p = 0.006; T test). After 6 months, contrast sensitivity declined again (+1.5 optotypes; p = 0.2; T test). Compared to the placebo group changes on VA failed statistical significance (p = 0.1 at 4 week; T test) whereas changes on contrast sensitivity were statistically significant (p = 0.01 at week 4; T test). No adverse events were seen or reported during the study period.
To the best of our knowledge, this is the first report of a transpalpebral electrostimulation in patients with dry AMD that demonstrates a temporary increase in visual function in some of these patients; results that seem to justify further research on this potential treatment option for dry AMD.
评估经皮电刺激治疗对干性年龄相关性黄斑变性（AMD）患者的疗效。
将 22 名患者随机分为两组，一组接受治疗（n = 12），另一组接受安慰剂治疗（n = 10）。两组之间的年龄和初始视力（VA）无统计学差异（p = 0.6；ANOVA）。治疗连续进行 5 天。每天进行两次治疗。每次治疗包括眼球周围的 8 个部位（40 秒/部位）。所应用的电流（频率在 5-80 Hz 之间变化）因人而异，介于 150-220 μA 之间。患者在治疗前、治疗结束时（第 5 天）、4 周后和 6 个月后接受检查。检查包括使用 ETDRS 字母进行标准化视力测试、对比敏感度、黄斑敏感度和使用微视野计和 SD-OCT 进行固视稳定性测量。
第 1 周结束时，平均 VA 明显改善（p = 0.001；T 检验），12 名患者中有 7 名 VA 提高超过 5 个字母。4 周后，3 名患者 VA 提高超过 10 个字母（平均提高 5.7 个字母；p = 0.001；T 检验），而 6 个月时 VA 下降 1.6 个字母。我们的患者中只有 4 名（33%）没有任何改善。对比敏感度也呈现出类似的模式。治疗后 1 周内，对比敏感度迅速提高（+4.4 个视标；p = 0.006；T 检验）。6 个月后，对比敏感度再次下降（+1.5 个视标；p = 0.2；T 检验）。与安慰剂组相比，VA 的变化无统计学意义（p = 0.1，4 周时；T 检验），而对比敏感度的变化有统计学意义（p = 0.01，4 周时；T 检验）。研究期间未出现或报告任何不良事件。
据我们所知，这是首例报道经皮电刺激治疗干性 AMD 患者的研究，该研究显示一些患者的视觉功能暂时提高；这些结果似乎证明了对干性 AMD 这种潜在治疗选择进行进一步研究是合理的。
