CTRI/2021/08/035994招募中不适用
Safety and efficacy of collagenase application in ocular burns: A prospective open- label academicrandomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of cases showing complete restoration (epithelialization) of the ocular surface on clinical slit-lamp evaluation using fluorescein staining.
研究概览
简要总结
We propose to investigate the drug Collagenase in a prospective open-label randomized controlled academic clinical trial. In particular, we aim at evaluating the safety and efficacy of topical collagenase for the treatment of adult patients with acute severe unilateral chemical burns. This trial will be single centre, performed at the LV Prasad Eye Institute (LVPEI), in Hyderabad, India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient should be 18 years and above of age.
- •2.Patient should be able and prepared to complete all required clincial tests and examinations.
- •3.Patient should be diagnosed with an acute (<14 days after injury) severe (grade II-IV) unilateral chemical burn.
- •4.Patient should not have any other ocular abnormality in the injured eye.
- •5.Able to provide informed consent prior to any study related procedures.
排除标准
- •Unwillingness to participate in the study.
结局指标
主要结局
Proportion of cases showing complete restoration (epithelialization) of the ocular surface on clinical slit-lamp evaluation using fluorescein staining.
时间窗: 28 days
次要结局
- The proportion of patients showing 2-line improvement in BCVA from baseline will be computed along with 95% CIs.(The secondary end points will be at 3-months, 6-months and 1-year follow up visit.)
研究者
研究点 (1)
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