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临床试验/NCT03927118
NCT03927118已完成不适用

The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc Morphology in Patients With Diabetic Maculopathy

Bulent Ecevit University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Peripapillary RNFL thickness measurements

研究概览

简要总结

This study evaluates the effect of dexamethasone implant which is an intraocular corticosteroid on the optic nerve fibers. Retinal nerve fiber thicknesses and optic nerve head pitting rates were measured before and 6 months after the injection.

详细描述

Diabetic macular edema is the most frequent ocular complication of diabetes resulting in irreversible loss of vision if untreated. Dexamethasone implant implant is used to treat macular edema due to diabetes. It stay in the vitreous for 6 months after intravitreal administration.

Dexamethasone implant can lead to retinal nerve fiber layer and optic nerve damage by both increasing intraocular pressure and its direct effect on neural tissue during the effective 6-month period.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Peripapillary RNFL thickness measurements

时间窗: six month

micrometer

次要结局

未报告次要终点

研究者

发起方
Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Atilla Alpay

Associate professor

Bulent Ecevit University

研究点 (1)

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