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.

All India Institute of Medical Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•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 Âµm)]
•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 Âµm
•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

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