Retrospective Non-Interventional Study to Evaluate the Patient Benefit of Transcorneal Electrostimulation (TES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Visual field
研究概览
简要总结
In this retrospective non-interventional study (NIS), the subjective and objective benefit of patients with retinitis pigmentosa (and other dystrophies like Usher, Choroideremia or cone-rod dystrophy), who have been prescribed the therapy of transcorneal electrostimulation (TcES) with the OkuStim System, is assessed.
详细描述
The medical device OkuStim received the CE mark (a symbol of free marketability in the European Economic Area) in 2011 and is commercially available for patients in Europe since 2014. Since then, patients with retinitis pigmentosa and other dystrophies have regularly applied the therapy of transcorneal electrostimulation (TcES) with OkuStim. So far, the benefits of the therapy and the experiences of the patients with regular, multi-year use have not been systematically recorded.
In this retrospective non-interventional study (NIS) with patients which have been using TcES since >1 year, data present for visual field, best-corrected visual acuity (BCVA) and central foveal thickness (as assessed via OCT) is collected. In addition, reasons for discontinuation of therapy and patient satisfaction with TcES are assessed via a questionnaire. Side-effects are also recorded, if present in the patient files.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Use of TcES for >1year
- •Willing and able to consent
排除标准
- •Not willing and able to consent
结局指标
主要结局
Visual field
时间窗: Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy.
Assessment of changes compared to baseline (before TcES was started)
次要结局
- Central foveal thickness(Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy.)
- Best-corrected visual acuity(Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy.)