DRKS00016583招募中未知
An open label, prospective, randomized, crossover, monocentric clinical trial to assess safety and performance of a retinal imaging laser eyewear system in patients with visual impairment caused by corneal diseases. - RILEW-01
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 21
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. Male or female outpatients, aged = 18 and = 85 years
- •2. Visually impaired according to legal definition (BCVA = 0.3)
- •3. Corneal opacities/diseases according to at least one of the following ICD-10 codes:
- •H16.- Keratitis
- •H17.- Corneal scars and opacities
- •H18.- Other disorders of the cornea
- •S05.- Injury of eye and orbit
- •T26.- Burn and corrosion confined to eye and adnexa
- •T81.- Complications of procedures
- •T86.0 - Bone-marrow transplant rejection
- •4. Best corrected visual acuity (BCVA) = 0.2 in the study eye
- •5. Difference between BCVA and VA assessed with retinometer =2 lines in the study eye
- •6. Ability to converse, read, and write fluently in German
- •7. Written informed consent
- •8. Subjects able and willing to attend all scheduled visits and comply with all study procedures and obligations
排除标准
- •Eligible subjects must not meet any of the following exclusion criteria:
- •1. Significant function loss within the study eye due to diseases other than listed in inclusion criterion No. 3 or due to any surgery to the posterior part of the eye
- •2. Subject unable to tolerate the RETISSA eyewear
- •3. Intended corneal transplantation in the study eye in the next four months
- •4. Central or peripheral diseases of the vestibular system (e.g. Ménière´s Disease, vestibular migraine, benign paroxysmal positional vertigo, etc.) that cause a clinically significant vertigo
- •5. Previous application of pharmaceuticals with retinal toxicity,
- •a. that have reached the cumulative doses in the patient or
- •b. where treatment of the patient has not been stopped within the time frame of 5 half-lives (of the respective pharmaceutical) prior to the screening visit or
- •c. for which treatment of the patient needs to be continued after screening
- •6. Diagnosed depression
- •7. Risk of non-compliance with study procedures (e.g. lack of cooperation)
- •8. Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent, or grandchild
- •9. Conditions, which, in the opinion of the investigator, would not allow save participation in this study (drug addiction, alcohol abuse, etc.)
- •10. Females currently pregnant or breast-feeding
- •11. Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device
- •12. Persons who are accommodated in an institution as a result of an official or judicial order
研究者
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