Trail with Corneal Implant

Phase 1

• Conditions: Health Condition 1: H171- Central corneal opacityHealth Condition 2: null- Corneal Edema with No Visual Potential

• Registration Number: CTRI/2019/07/020024
• Lead Sponsor: Eye Yon Medical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency and severity of all treatment-related adverse events, during and after implantation of the EndoArtâ?¢ and throughout the 6-month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infectionTimepoint: Day 1, 7,14 <br/ ><br>Week 4, 6, 8,10,12 <br/ ><br>Month 4, 5,6, 8,10,12

Secondary Outcome Measures

Name	Time	Method
Corneal ClarityTimepoint: baseline, week 4, 6, 8, 12 <br/ ><br>Month 6 ,12;Corneal Thickness <br/ ><br>Timepoint: baseline, week 4, 8, 12 <br/ ><br>Month 6 ,12;Pain Assessment by a Visual Analogue Scale (VAS)Timepoint: baseline, week 4, 8, 12 <br/ ><br>Month 6 ,12