Trail with Corneal Implant

Prospective Investigator Initiated Study to Evaluate the Biocompatibility and Indicative effectiveness of EndoArt in Subjects Having Corneal Edema with No Visual Potential - Not Applicable

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020024

Enrollment

Registered

2019-07-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Corneal Implant EndoArt: Artificial Endothelial Layer made of biocompatible Silicone coated on one side with thermosensitive layer of pNIPAM polymerized binding agent Intervention2: End

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male Female Subject is over 50 years old 2. No Visual Potential 3. Clinical Corneal Edema 4. Corneal thickness >650 Î¼m 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

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 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.

Design outcomes

Primary

Measure	Time frame
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 Week 4, 6, 8,10,12 Month 4, 5,6, 8,10,12	—

Measure

Time frame

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 Week 4, 6, 8,10,12 Month 4, 5,6, 8,10,12

—

Secondary

Measure	Time frame
Corneal ClarityTimepoint: baseline, week 4, 6, 8, 12 Month 6 ,12;Corneal Thickness Timepoint: baseline, week 4, 8, 12 Month 6 ,12;Pain Assessment by a Visual Analogue Scale (VAS)Timepoint: baseline, week 4, 8, 12 Month 6 ,12	—

Countries

India

Contacts

Public ContactDr Prashant Garg

LV Prasad Eye Institute

prashant@lvpei.org04030612555

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026