CTRI/2019/07/020024招募中1 期
Prospective Investigator Initiated Study to Evaluate the Biocompatibility and Indicative effectiveness of EndoArt in Subjects Having Corneal Edema with No Visual Potential - Not Applicable
Eye Yon Medical Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1. Male Female Subject is over 50 years old
- •2. No Visual Potential
- •3. Clinical Corneal Edema
- •4. Corneal thickness >650 μm
- •5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
- •6. Pseudophakic subject (anterior or posterior) with stable IOL.
排除标准
- •1. History of ocular Herpes keratitis
- •2. Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
- •3. Irregular posterior cornea (e.g. post PKP)
- •4. Active infection of the cornea
- •5. Band keratopathy and/or limbal stem cell deficiency.
- •6. Moderate to severe dry eye
- •7. Subject with phthisis or phthisis suspect
- •8. Very low ocular pressure <=6 mmHg or higher than 25 mmHg.
- •9. Aphakia or subluxated lens or pseudophacodonesis
- •10. Subject with glaucoma shunt (e.g. Ahmend valve)
- •11. Subject with large iris defect which can compromise intraoperative AC stability.
- •12. Subjects after corneal refractive surgery.
- •13. Subject with neurotrophic corneal history
- •14. Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization)
- •15. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days.
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