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 Sciences1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2023年1月7日最近更新: 2024年10月25日

试验速览

阶段: 1 期
状态: 尚未招募
发起方: All India Institute of Medical Sciences
入组人数: 20
试验地点: 1
主要终点: healing of ulcer, maintenance of glove integrity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•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)]
•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.

排除标准

•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, adnexal infections, retinal pathology and glaucoma.

结局指标

主要结局

healing of ulcer, maintenance of glove integrity

时间窗: Months 1,3,6 and 12

次要结局

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)

研究者

发起方

All India Institute of Medical Sciences

申办方类型

Research institution and hospital

研究点 (1)

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