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临床试验/NCT07145008
NCT07145008招募中1 期

Suprachoroidal Triamcinolone in Macular Edema for Patients With Non-Infectious Uveitis Resistant to Subtenon Triamcinolon

Baghdad college of medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月1日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Visual acuity improvement

研究概览

简要总结

The goal of this study is to learn if a suprachoroidal triamcinolone injection can treat vision-threatening swelling in the center of the retina (macular edema) caused by non-infectious uveitis, especially in people who did not improve after a standard steroid injection around the eye (sub-Tenon injection).

The main questions it aims to answer are:

Does vision improve on the eye chart after the injection?

Does the injection lower retinal swelling (reduction in thickness) within 3 months?

Participants will:

Have a pre-treatment check (vision test, slit-lamp exam, and a retinal scan called OCT).

Receive one suprachoroidal triamcinolone injection under anesthetics drops in a sterile setting (operating room) with standard monitoring.

Return for visits about 1 month and 3 months after treatment for repeat vision tests, and OCT scans.

Contact the clinic if they notice pain, redness, new floaters, or worsening vision.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-infectious uveitis complicated with macular edema
  • Uveitic macular edema of less than four months' duration
  • Macular edema persisted despite lack of intra-ocular inflammation
  • No response to posterior sub-Tenon triamcinolone acetonide injections

排除标准

  • Those with epiretinal membrane-associated macular edema
  • Below 18 years

研究组 & 干预措施

Suprachoroidal Triamcinolone treatment arm

Experimental

干预措施: Suprachoroidal triamcinolone acetonide injection (Drug)

结局指标

主要结局

Visual acuity improvement

时间窗: 3 months

visual acuity improvement was defined as a gain of two or more lines in visual acuity or a reduction in logMAR values

次要结局

  • Central Macular Thickness(3 Months)

研究者

发起方
Baghdad college of medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Mutar

Medical Doctor

Baghdad college of medicine

研究点 (1)

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