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

INTERVENTION: 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 damaged cornea in infectious keratitis cases and corneal opacity cases. The intervention cases will be operated using the bioengineered decellularised preserved cornea (intervention agent) Control Intervention1: Fresh human cornea: Intervention will be the use of fresh human corneas. Lamellar keratoplasty (LK) will be performed for replacing the damaged cornea in infectious keratitis cases and corneal opacity cases. The comparator agent will be fresh human corneas. CONDITION: Health Condition 1: O‐ Medical and Surgical PRIMARY OUTCOME: healing of ulcer, maintenance of glove integrityTimepoint: Months 1,3,6 and 12 SECONDARY OUTCOME: Best corrected visual acuityTimepoint: Months 1,3,6 and 12 safety data (any ocular complication noticed after surgery)Timepoint: 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 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.