临床试验/NCT04400916

NCT04400916Unknown不适用

Topical Use of Tranexamic Acid for Prevention of Subconjunctival Hemorrhage After Intravitreal Injections

Rambam Health Care Campus0 个研究点目标入组 100 人开始时间: 2020年9月最近更新: 2020年5月26日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Rambam Health Care Campus
入组人数: 100
主要终点: Subconjunctival hemorrahge

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

We aim to investigate whether topical administration of Tranexamic acid can reduce the occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal conditions.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Subjects receiving intravitreal injections as part of their routine ophthalmological care

排除标准

•Pregnancy, Oral contraceptives/HRT use, Known systemic autoimmune disease, Renal failure, active/suspected infection or inflammation in the treated eye, subconjunctival hemorrahge prior to inclusion, History of subarachnoid hemorrahge, thromboembolic events, increased risk for thromboembolic events, known sensitivity to the study drug

研究组 & 干预措施

Topical tranexamic acid

Experimental

干预措施: Tranexamic acid (Drug)

Topical BSS

Placebo Comparator

干预措施: Balanced Salt Solution (Other)

结局指标

主要结局

Subconjunctival hemorrahge

时间窗: 3 days

次要结局

未报告次要终点

研究者

发起方

Rambam Health Care Campus

申办方类型

Other

责任方

Principal Investigator

主要研究者

Shiri Soudry MD

Attending faculty and vitreoretinal surgeon, Department of Ophthalmology

Rambam Health Care Campus

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