A Prospective Randomized Controlled Clinical Trial to Compare the Safety and Efficacy of Topical Cord Blood Serum Drops and Amniotic Membrane Transplantation in Acute Chemical Injury
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 3.CORNEAL CLARITY
研究概览
简要总结
PURPOSE: A PROSPECTIVE RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE SAFETY AND EFFICACY OF TOPICAL CORD BLOOD SERUM DROPS AND AMNIOTIC MEMBRANE TRANSPLANTATION IN ACUTE CHEMICAL INJURY
DESIGN: RANDOMIZED, CONTROLLED, CLINICAL TRIAL
PARTICIPANTS AND CONTROLS: PARTICIPANTS WITH ACUTE CHEMICAL INJURY WERE RANDOMIZED INTO 3 GROUPS
INTERVENTION: GROUP 1 TREATED WITH STANDARD TREATMENT, GROUP 2 WITH AMNIOTIC MEMBRANE GRAFT IN ADJUNCTION TO STANDARD TREATMENT, GROUP 3 TREATED WITH CORD BLOOD SERUM IN ADJUNTION TO STANDARD TREATMENT
MAIN OUTCOME MEASURES: VISUAL ACUITY, DUA’S CLASSIFICATION, CORNEAL CLARITY, LIMBAL INVOLVEMENT, EPITHELIAL DEFECT, PAIN SCORE, TEAR FILM STATUS, INTRAOCULAR PRESSURE, OTHER COMPLICATIONS
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 5.00 Year(s) 至 52.00 Year(s)（—）
- 性别
- All
入选标准
- •GRADE 3,4,5 CHEMICAL INJURY AS PER DUAS CLASSIFICATION PRESENTING WITH IN 3 WKS OF INJURIES.
排除标准
- •GRADE 1,2,6 CHEMICAL INJURY AS PER DUAS CLASSIFICATION PRESENTING WITH IN 3 WKS OF INJURIES 2.IMPENDING PERFORATION OR PERFORATION AT PRESENTATION 3.NOT WILLING FOR PARTICIPATION OR FOLLOW UP.
结局指标
主要结局
3.CORNEAL CLARITY
时间窗: 3 MONTHS
1.VISUAL ACUITY
时间窗: 3 MONTHS
5.LIMBAL INVOLVEMENT
时间窗: 3 MONTHS
2.DUAS CLASSIFICATION
时间窗: 3 MONTHS
4.EPITHELIAL DEFECT
时间窗: 3 MONTHS
次要结局
- 1.PAIN SCORE(2.TEAR FILM STATUS)