NL-OMON53003已完成不适用
Prospective, Feasibility study to evaluate the safety of the EndoArt* for Treatment of Subjects Suffering from Corneal Edema - Safety of the EndoArt* for Treatment of Corneal Edema
EyeYon Medical0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is over 40 years old
- •2. Subject with chronic corneal edema.
- •3. Subject with corneal thickness >650 µm
- •4. Subject with visual acuity 6/30 or worse (equivalent ETDRS).
- •5. Subject with better visual acuity in the contralateral eye.
- •6. Pseudophakic subject (anterior or posterior) with stable IOL.
- •7. Subject understands the study requirements and the treatment procedures and
- •provides written Informed Consent before any study-specific tests or procedures
- •are performed.
排除标准
- •1. Subject with best corrected visual acuity of 6/30 or worse in the fellow eye
- •2. Subject with history of ocular Herpes keratitis
- •3. Subject with severely scarred cornea (unfit for regular endothelial
- •keratoplasty)
- •4. Subject with irregular posterior cornea (e.g. post PKP)
- •5. Subject who is suffering from infection of the cornea
- •6. Patients with band keratopathy and/or limbal stem cell deficiency.
- •7. Subject with clinical moderate to severe dry eye
- •8. Subject with phthisis or phthisis suspect
- •9. Subject with low ocular pressure *6 mmHg or higher than 25 mmHg.
- •10. Subject with aphakica
- •11. Subject with pseudophakodonesis
- •12. Subject with large iris defect which can compromise intraoperative AC
- •13. Subjects after corneal refractive surgery.
- •14. Subject with glaucoma shunt (e.g. Ahmend valve)
- •15. Subject with neurotrophic corneal history
- •16. Subject with history of persistent corneal erosion difficulties with
- •epithelial growth (re-epithelization)
- •17. Subject who is currently participating or have participated in an
- •investigational study, other than this study, within the past 60 days
研究者
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