Erb Carl, Eckert Sophie, Gindorf Pia, Köhler Martin, Köhler Thomas, Neuhann Lukas, Neuhann Thomas, Salzmann Nadja, Schmickler Stefanie, Ellrich Jens
Augenklinik Wittenbergplatz, Berlin, Germany.
Medizentrum Eckert, Neu-Ulm, Germany.
Bioelectron Med. 2022 Mar 31;8(1):6. doi: 10.1186/s42234-022-00089-9.
The retrospective study provides real-world evidence for long-term clinical efficacy of electrical optic nerve stimulation (ONS) in glaucoma with progressive vision loss.
Seventy glaucoma patients (45 to 86 y) with progressive vision loss despite therapeutic reduction of intraocular pressure (IOP) underwent electrical ONS. Closed eyes were separately stimulated by bipolar rectangular pulses with stimulus intensities up to 1.2 mA sufficient to provoke phosphenes. Ten daily stimulation sessions within 2 weeks lasted about 80 min each. Right before ONS at baseline (PRE), vision loss was documented by static threshold perimetry and compared to the same assessment approximately 1 year afterwards (POST). Mean defect (MD) was defined as primary outcome parameter. Perimetries with a reliability factor (RF) of max. 20% were considered.
Perimetry follow-up of 101 eyes in 70 patients fulfilled the criterion of a max. 20% RF. Follow-up was performed on average 362.2 days after ONS. MD significantly decreased from PRE 14.0 dB (median) to POST 13.4 dB (p < 0.01). 64 eyes in 49 patients showed constant or reduced MD as compared to baseline (PRE 13.4 dB vs. POST 11.2 dB). In 37 eyes of 30 patients, MD increased from PRE 14.9 dB to POST 15.6 dB.
Innovative treatments that preserve visual function through mechanisms other than lowering IOP are required for glaucoma with progressive vision loss. The present long-term data document progression halt in more than 63% of affected eyes after ONS and, thus, extend existing evidence from clinical trials.
这项回顾性研究为视神经电刺激（ONS）对进行性视力丧失的青光眼患者的长期临床疗效提供了真实世界的证据。
70例尽管眼压（IOP）经治疗已降低但仍有进行性视力丧失的青光眼患者（45至86岁）接受了视神经电刺激。双眼闭合，分别用双极矩形脉冲进行刺激，刺激强度高达1.2毫安，足以诱发光幻视。在2周内每天进行10次刺激，每次持续约80分钟。在基线（PRE）进行ONS之前，通过静态阈值视野检查记录视力丧失情况，并与大约1年后的相同评估（POST）进行比较。平均缺损（MD）被定义为主要结局参数。考虑可靠性系数（RF）最大为20%的视野检查。
70例患者的101只眼的视野检查随访符合最大20% RF的标准。ONS后平均362.2天进行随访。MD从PRE时的中位数14.0 dB显著降至POST时的13.4 dB（p < 0.01）。49例患者的64只眼与基线相比MD保持不变或降低（PRE为13.4 dB，POST为11.2 dB）。30例患者的37只眼中，MD从PRE时的14.9 dB增加到POST时的15.6 dB。
对于进行性视力丧失的青光眼，需要通过降低眼压以外的机制来保护视觉功能的创新治疗方法。目前的长期数据表明，ONS后超过63%的患眼病情停止进展，从而扩展了临床试验的现有证据。
