Röck T, Naycheva L, Willmann G, Wilhelm B, Peters T, Zrenner E, Bartz-Schmidt K U, Gekeler F, Schatz A
Department für Augenheilkunde, Eberhard Karls Universität Tübingen, Tübingen, Deutschland.
Klinik für Augenheilkunde, Universitätsklinikum Frankfurt, Frankfurt am Main, Deutschland.
Ophthalmologe. 2017 Oct;114(10):922-929. doi: 10.1007/s00347-016-0415-5.
Recently, reports have been published on the effectiveness of electrical stimulation in patients and experimental animal models with neurodegenerative ocular diseases. Our study included 14 patients with primary open angle glaucoma (POAG), who were randomized into one of three groups with 0% (sham, n = 5), 66% (n = 5) or 150% (n = 4) of their individual electrical phosphene thresholds. Patients were treated with transcorneal electrical stimulation (TES) for 30 min once a week for 6 consecutive weeks. Outcome measures of our study were the detection of possible adverse events and efficacy of TES using DTL electrodes in subjective and objective parameters of visual function under treatment. TES was tolerated well and no serious adverse events were registered relating to the treatment. One single adverse event was registered as appearance of an optic disc hemorrhage of a sham-stimulated eye. In summary, one significant increase of intra-ocular pressure in the 66% group was observed in comparison to the sham group (p = 0.04), without significant differences compared to the 150% group (both sham vs. 150% group and 66% vs. 150% group). This difference (mean difference compared to baseline of -2.33 mm Hg for the sham group and +0.97 mm Hg for the 66% group; REML) was not clinical meaningful. All other findings, including results of the visual field, were not statistically significant different between groups. It was shown that TES using DTL electrodes did not trigger adverse or serious adverse events in the stimulated groups in patients with POAG. Patients with POAG should currently receive TES only under study conditions.
最近,关于电刺激对患有神经退行性眼病的患者和实验动物模型有效性的报告已发表。我们的研究纳入了14例原发性开角型青光眼(POAG)患者,他们被随机分为三组,分别接受其个体电光幻视阈值0%(假刺激,n = 5)、66%(n = 5)或150%(n = 4)的刺激。患者接受经角膜电刺激(TES),每周一次,每次30分钟,连续6周。我们研究的结果指标是检测可能的不良事件以及在治疗期间使用DTL电极进行TES对视觉功能主观和客观参数的疗效。TES耐受性良好,未记录到与治疗相关的严重不良事件。记录到1例不良事件,为假刺激眼出现视盘出血。总之,与假刺激组相比,66%组观察到1例眼压显著升高(p = 0.04),与150%组相比无显著差异(假刺激组与150%组以及66%组与150%组)。这种差异(与基线相比,假刺激组平均差异为-2.33 mmHg,66%组为+0.97 mmHg;REML)无临床意义。所有其他结果,包括视野结果,组间差异均无统计学意义。结果表明,在POAG患者的刺激组中,使用DTL电极进行的TES未引发不良或严重不良事件。目前,POAG患者仅应在研究条件下接受TES治疗。