跳至主要内容
临床试验/CTRI/2024/03/064249
CTRI/2024/03/064249尚未招募3 期

A multicentric randomised control trial comparing percentage of optical grade donor human corneas and endotheial cell density between traditional and modified corneoscleral rim excision techniques- a surgical technique trial

BIRAC-DBT3 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年3月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
500
试验地点
3
主要终点
Endothelial Cell density on sepcular Microscopy

研究概览

简要总结

Corneal transplantation is the most successful type of organ transplantation. Thus far the eye donation movement in India has gained tremendous momentum owing to widespread awareness and a major paradigm shift in public attitude. However, of collected tissues only half are used for transplantation purposes. The remaining are utilized for medical education or experimental research and a large proportion of non-utilization due to multiple reasons- most often due to poor quality. Poor quality tissues are likely to result in primary graft failure after corneal transplantation. It is therefore of utmost importance to protect the corneal endothelium and improve the viability of the cells during harvesting itself.  Current techniques of harvesting of cornea rely on skill set of the technician/resident/doctor for preventing damage to the corneal tissues during harvesting. By this study we intend to improve the vitality of the cells and decrease intra harvesting damage to the corneal endothelium. This will eventually improve the Quality of tissues harvested and decrease the wastageThe trial is step forward to improve the health of donor corneas that are harvested after death. We are using clinically proven medications that are routinely used in ophthalmic surgery, for comparing the health and cell counts by a simple modification of the existing harvesting technique. 4 eye bank centers are enrolled for the project.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

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

入选标准

  • All Corneas Harvested from Eye Bank
  • Consecutive recruitment
  • Death to collection time less than 6 hours (with or without body cooling).

排除标准

  • Death to collection time more than 6 hours
  • Accidental injury during tissue transport
  • Improper harvesting technique
  • Vitreous loss during collection of tissue.

结局指标

主要结局

Endothelial Cell density on sepcular Microscopy

时间窗: 1. Post Harvesting Day 1

次要结局

  • No of Rejected tissues I vs II(1. Post harvesting day 4)
  • Percentage Hexagonality(1. Post Harvesting Day 1)
  • Area of cell(1. Post Harvesting Day 1)
  • No Of Cells Counted(1. Post Harvesting Day 1)
  • Rejected Tissues vital cell analysis(1. Post Harvesting Day 4)

研究者

发起方
BIRAC-DBT
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Charuta J Puranik

Oculus Regenerus Eye Care and Research Center

研究点 (3)

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