DRKS00023562已完成4 期
Evaluation of the effectiveness of transcorneal electrostimulation in patients with retinitis pigmentosa - a multicenter, prospective, randomized, controlled and double-blind study on behalf of the G-BA - TES-RP
niversitätsklinikum Tübingen0 个研究点目标入组 141 人开始时间: 2021年2月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. patients with syndromal or non-syndromal RP (autosomal dominant, auto-somal recessive and X-linked)
- •2. adults of all sexes aged 18 - 80 years
- •3. BCVA (ETDRS visual acuity) between 0.1 and 0.8 in both eyes with no more than 15 ETDRS letters (3 lines) difference between eyes
- •4. octopus 900, kinetic visual field
- •a. Visual field area equal to or greater than 75 deg2 (corresponding to an average radius of 5 degrees; stimulus V4e) in both eyes.
- •b. The difference between the two eyes must have a ratio OD/OS not less than 0.5 and not more than 2
- •5. able and willing to give written informed consent for the study
排除标准
- •Ophthalmic exclusion criteria:
- •1. optic neuritis / optical neuropathy.
- •2. diabetic retinopathy
- •3. neovascularization of the retina of different genesis
- •4. condition after retinal artery or vein occlusion
- •5. condition after retinal detachment or vitreoretinal surgery
- •6. silicone oil tamponade
- •7. dry or neovascular AMD
- •8. macular edema (SD-OCT)
- •9. glaucoma
- •10. corneal degeneration affecting visual acuity
- •11. opacity of refractive media affecting OCT/FP/ophthalmoscopy (lens classification).
- •12. cataract which, in the opinion of the investigator, may require surgery during the study period
- •13. aphakia
- •14. TES therapy in the last 3 months
- •Further exclusion criteria
- •15. any chronic, non-controllable or unmanaged disease, e.g., but not limited to, cardiac or pulmonary disease, which increases the patient's risk during study participation
- •16. poor general health that, in the opinion of the investigator, makes it difficult for the patient to reliably participate in visit appointments or to complete therapy
- •17. mental illnesses such as bipolar disorder, schizo-affective disorder, addictions or dementia
- •18. neurological diseases such as epilepsy or Parkinson's disease, which may pose a problem for the application of the therapy
- •19. concurrent participation in other intervention studies or history of study participation, the effects of which may be ongoing
- •20. active implants (except cochlear implants in a deactivated state)
- •21. pregnancy or childbearing women of childbearing potential or lactation
- •22. basic concerns of the investigator that the patient is capable and fit to participate.
- •23. allergies to the materials used in the TES.
研究者
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