Phase I Clinical trial for bioengineered decellularised cross-linked human corneal graft : A novel therapeutic approach to combat corneal blindness in India.

Phase 1

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/05/052622
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

This clinical trial aims to evaluate the feasibility, safety, and tolerability of bioengineered, decellularized, and cross-linked human corneal grafts for keratoplasty in patients with corneal infections and corneal opacity with a comparison of outcomes from fresh human corneal grafts. As an academic clinical trial- Phase I (pilot clinical study), study focuses on assessing the safety and feasibility of decellularized bioengineered corneal grafts based on primary and secondary outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-07
• Last Update Posted: 2024-10-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1.Age aged 18 years of age or above 2.Unilateral/ bilateral infectious keratitis or corneal opacity, satisfying the following criteria: [The patients undergoing emergency partial-thickness keratoplasty for corneal infections (severe corneal ulcers or melts, with depth <80% of corneal thickness and size < 7mm) or corneal opacities (with depth of opacities upto 400 µm)] 3.
• Willing to participate and follow-up for at least 6 months 4.Patient who able to give consent for the intervention.
• In cases where the patient is not able to give consent, then Legal Acceptable Representative (LAR) will do the same on behalf of patients.

Exclusion Criteria

• b) Exclusion Criteria: 1.Those with corneal thickness <450 µm 2.Those with limbus-to-limbus extent of corneal infection.
• 3.Patients with untreated concurrent ocular conditions, such as adnexal problems, adnexal infections, retinal pathology and glaucoma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
healing of ulcer, maintenance of glove integrity	Months 1,3,6 and 12

Secondary Outcome Measures

Name	Time	Method
safety data (any ocular complication noticed after surgery)	Months 1,3,6 and 12
Best corrected visual acuity	Months 1,3,6 and 12
survival of the graft (status of graft clarity or transparency, rate of epithelisation of graft, neovascularization)	Months 1,3,6 and 12

Trial Locations

Locations (1)

DR RAJENDRA PRASAD CENTRE, All India Institute of medical Sciences; 🇮🇳 South, DELHI, India

DR RAJENDRA PRASAD CENTRE, All India Institute of medical Sciences

🇮🇳South, DELHI, India

Prof Radhika Tandon

Principal investigator

01126593145

radhika_tan@yahoo.com