透视角电刺激用于治疗视野缺陷的患者与开放角青光眼:一个单心,随机,双面罩,假控制的试点研究:TES-GPS研究协议
Katrin Lorenz1, Alexander Schuster2, Helena Maria Michel2
1Department of Ophthalmology, University Medical Center, Johannes Gutenberg University, Mainz, Germany katrin.lorenz@unimedizin-mainz.de.
BMJ open
|February 9, 2026
概括
经角膜电刺激 (TES) 显示,在对标准治疗无反应的患者中,有可能减缓青光眼的进展. 本试点研究评估了使用OkuStim 2系统保护视网膜功能的TES的安全性和有效性.
科学领域:
- 眼科医生 眼科 眼科
- 神经科学是一个神经科学.
- 医疗器械 医疗器械
背景情况:
- 玻璃眼是不可逆转的失明的主要原因,原因是视网膜质细胞的逐渐丧失.
- 目前降低眼内压力的治疗方法对于持续疾病进展的部分患者来说是不够的.
- 经角膜电刺激 (TES) 通过激活可能减缓视野缺陷的途径,提供了潜在的神经保护方法.
研究的目的:
- 为了研究Okustim 2系统的安全性和有效性,用于在患有开角玻璃眼的患者中进行跨角膜电刺激 (TES).
- 评估TES的潜力,以减缓青光眼患者视野损失的进展.
- 评估二级终点,包括视力敏度,眼内压,OCT参数和生活质量.
主要方法:
- 一项前性,随机化,双盲,假控制,单中心试点研究 (TES-GPS) 涉及50名患有开角玻璃眼的患者.
- 参与者被随机分配1:1接受Okustim 2系统或假刺激的TES.
- 主要终点是视野敏感度在18个月内发生的变化,每周进行30分钟的家庭会议.
主要成果:
- 这项研究正在进行中,主要/次要终点尚未确定.
- 关于TES申请的安全数据将被收集和分析.
- 减缓视野损失的有效性将通过将活跃的TES组与假组进行比较来评估.
结论:
- 使用OkuStim 2系统的TES提出了一种针对眼的新疗法策略.
- 需要进一步的研究来证实TES的长期安全性和疗效,以治疗青光瘤.
- 积极的研究结果可能会导致尽管目前的治疗方法,但对渐进性玻璃眼患者的新治疗选择.
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