Randomized clinical trial to assess the efficacy of Suprachoroidal Triamcinolone Acetate injection in Non-infectious Uveitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Improvement in visual acuity
研究概览
简要总结
Uveitis is a group of intraocular inflammatory disorders affecting the uveal tract and surrounding tissues and is responsible for up to 15% of all cases of complete blindness in the developed world. It can be broadly classified as infectious and non-infectious uveitis (NIU). Each type is further classified based on anatomical location. Anterior uveitis is the most common entity comprising around 45%, followed by panuveitis (25%), while intermediate & posterior uveitis constitutes 15% of all cases.
Treatment of posterior uveitis is difficult as delivering efficacious levels of therapeutic agents is challenging and can lead to visual morbidity. Control of inflammation, preventing sight-threatening complications and minimizing recurrences are the main therapeutic goals. The most common complication of chronic NIU is cystoid macular edema (CME) leading to vision impairment in one-third of all uveitis patients, followed by choroidal neovascularization (CNV). Macular edema may persist even after inflammation is controlled; therefore, interventions should aim to resolve both inflammation and macular edema.
Present study is designed to study the role of triamcinolone acetonide injection in suprachoroidal space in different types of non-infectious uveitis for safety, efficacy, early recovery and prevention of relapse
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Newly diagnosed patients of all types (Anterior, intermediate, posterior and pan) uveitis Patients who give informed consent for the study.
排除标准
- •uncontrolled glaucoma, uncontrolled diabetes, or any other active ocular disease or infection.
结局指标
主要结局
Improvement in visual acuity
时间窗: (0,1,3,15) day | (1,3,6) month
Reduction in inflammation
时间窗: (0,1,3,15) day | (1,3,6) month
次要结局
- Reduction in central macular thickness(0 day, 1 month, 6 month)
研究者
Dr Perwez Khan
GSVM Medical College Kanpur
