Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 7
- 主要终点
- ophthalmic examinations
研究概览
简要总结
The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.
详细描述
This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist
- •adult patients who are capable of giving consent,
- •Visual acuity ≥ 0.02
- •because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)
- •the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol
排除标准
- •diabetic retinopathy
- •neovascularisation of any origin
- •after arterial or venous occlusion
- •after retinal detachment
- •silicone oil tamponade
- •dry or exudative age-related macular degeneration
- •macular edema
- •all forms of glaucoma
- •any form of corneal degeneration that reduces visual acuity
- •systemic diseases that are difficult to control or manage, that could endanger the normal study schedule
- •patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic
- •forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia
- •simultaneous participation in another interventional study or history of interventions whose effect may still persist
研究组 & 干预措施
OkuStim
Electrostimulation Standard Treatment with OkuStim
干预措施: Transcorneal electrostimulation (Device)
结局指标
主要结局
ophthalmic examinations
时间窗: 6 months
visual acuity slit lamp microscopy for examination of the anterior and posterior segment intraocular pressure measurement visual field examination Optical coherence tomography (OCT) Digital colour fundus photography
次要结局
- Questionnaires(6 months)