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

Phase I Clinical trial study to explore the feasibility and evaluate the clinical outcomes and safety of keratoplasty using bioengineered decellularized cross-linked human corneal graft in comparison to fresh human corneas: A novel therapeutic approach to combat corneal blindness in India.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052622

Enrollment

Registered

2023-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Decellularised bioengineered cross-linked human corneal graft: Intervention will be the use of bioengineered corneas.Lamellar keratoplasty (LK) will be performed for replacing the damag

Eligibility

Inclusion criteria

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 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

Exclusion criteria: b) Exclusion Criteria: 1. Those with corneal thickness 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

Design outcomes

Primary

Measure	Time frame
healing of ulcer, maintenance of glove integrityTimepoint: Months 1,3,6 and 12	—

Secondary

Measure	Time frame
Best corrected visual acuityTimepoint: Months 1,3,6 and 12;survival of the graft (status of graft clarity or transparency, rate of epithelisation of graft, neovascularization)Timepoint: Months 1,3,6 and 12;safety data (any ocular complication noticed after surgery)Timepoint: Months 1,3,6 and 12	—

Countries

India

Contacts

Public ContactDr Radhika Tandon

All India Institute of Medical Sciences(AIIMS)

radhika_tan@yahoo.com

Outcome results

None listed

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