Amniotic Membrane Transplantation in Acute Ocular Burns: a randomized controlled clinical trial

Indian Council of Medical Research1 个研究点分布在 1 个国家目标入组 100 人开始时间: 待定

试验速览

阶段: 不适用
发起方: Indian Council of Medical Research
入组人数: 100
试验地点: 1
主要终点: Rate of healing of corneal epithelial defect,

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 study was a prospective, randomized, controlled clinical trial to compare the efficacy of amniotic membrane transplantation in addition to standard medical therapy in patients with acute chemical or thermal ocular injury in terms of rate of healing of corneal epithelial defect, visual acuity, extent of corneal vascularization, corneal clarity and formation of symblepharon. We found that amniotic membrane transplantation in eyes with moderate ocular burns promotes faster healing of epithelial defect in patients with moderate grade burns.

研究设计

分配方式: Stratified randomization
盲法: Participant and Outcome Assessor Blinded

入排标准

入选标准

•Moderate and severe acute ocular burns.

排除标准

•Mild ocular burns, Patients who refused consent and were not available for follow up.

结局指标

主要结局

Rate of healing of corneal epithelial defect,

时间窗: day 1, day 7, weekly until 1 month, biweekly until 3 months, and monthly thereafter.

次要结局

visual acuity, extent of corneal vascularization, corneal clarity and formation of symblepharon.(day 1, day 7, weekly until 1 month, biweekly until 3 months, and monthly thereafter.)

研究者

发起方

Indian Council of Medical Research

研究点 (1)

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