Phase I Clinical trial for bioengineered decellularised cross-linked human corneal graft : A novel therapeutic approach to combat corneal blindness in India.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/05/052622
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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, infections, retinal pathology and glaucoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method