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临床试验/NCT05345808
NCT05345808已完成不适用

Efficacy of Formulated Posterior Sub Tenon Triamcinolone in 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 46 人开始时间: 2021年3月1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
46
试验地点
1
主要终点
Best corrected visual acuity

研究概览

简要总结

Retinal vein occlusion (RVO) is considered the second vascular disorder of the retina after diabetic retinopathy. Patients with RVO are at risk of the development of macular edema. Different treatment modalities for macular edema include LASER therapy, antivascular endothelial growth factor (VEGF), and triamcinolone.

Aim To detect the efficacy of formulated Triamcinolone Acetonide(TA) injection in the posterior subtenon space to manage macular edema secondary to non-ischemic RVOs, either central or branch.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diminution of vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch
  • CMT ≥ 250 µ,
  • Willing to participate in the study.

排除标准

  • Unwilling to participate in the study
  • Ischemic RVO
  • previous laser treatment
  • Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris
  • patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion
  • Cardiac co-morbidities result in significant hemodynamic changes
  • Respiratory diseases need treatment with antibiotics
  • Suffering from other chronic diseases as diabetes
  • Patient with allergy from triamcinolone acetonide.

研究组 & 干预措施

Formulated Posterior Sub Tenon Triamcinolone

Other

All the eyes received single dose 40 mg of Triamcinolone Acetonide (TA) and VISCOAT which is 20 mg sodium chondroitin sulphate and 15 mg sodium hyaluronate (0.5 ml) through posterior subtenon route using NAGATA subtenon canula.

干预措施: Triamcinolone Acetonide (Drug)

结局指标

主要结局

Best corrected visual acuity

时间窗: at 6th month

Measured by snellen chart

Central macular thickness

时间窗: at 6th month

Measured by Optical coherence tomography (OCT)

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

Akram Fekry Elgazzar

Clinical Professor

Al-Azhar University

研究点 (1)

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