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临床试验/NCT05385562
NCT05385562已完成不适用

Formulated Posterior Subtenon Triamcinolone (PSTA) Injection Versus Posterior Subtenon Triamcinolone Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
central macular thickness ( CMT)

研究概览

简要总结

The aim of this study is to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone in the management of macular edema secondary to non-ischemic retinal vein occlusions, either central or branch.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Diminution vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch, as evidenced by clinical and angiographic evaluation
  • CMT ≥ 250 µ.
  • Willing to participate in the study

排除标准

  • Unwilling to participate in the study.
  • Ischemic RVO
  • Prior laser treatment
  • Glaucoma/Ocular Hypertension
  • Cataract which lead to difficulty in the evaluation of macula
  • Vitreous hemorrhage
  • Macular ischemia
  • Iris neovascularisation
  • patients with intravitreal injection of anti VEGFs, steroid, or any intraocular surgery 3 months prior to the inclusion.

研究组 & 干预措施

Formulated Posterior Sub Tenon Triamcinolone

Active Comparator

干预措施: Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate (Drug)

Posterior Sub Tenon Triamcinolone alone

Active Comparator

干预措施: Triamcinolone Acetonide alone (Drug)

结局指标

主要结局

central macular thickness ( CMT)

时间窗: at 6th month

CMT will be measured with OCT

Best-corrected visual acuity (BCVA)

时间窗: at 6th month

will be measured with the Snellen chart

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ehab tharwat

Dr

Al-Azhar University

研究点 (1)

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