Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in Mean Visualization Score at Post-Instillation from Pre-Instillation
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide suspension when used for visualization of structures in the back of the eye during eye surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patients under
- •Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Triamcinolone
Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
干预措施: Triamcinolone Acetonide Injectable Suspension (Drug)
结局指标
主要结局
Change in Mean Visualization Score at Post-Instillation from Pre-Instillation
时间窗: Day 0
A video image of the posterior segment structures of the eye was taken before instillation of the test product and after. An independent masked reader evaluated the images and graded the degree of visualization on a 5-point scale ranging from 1 to 4 and anchored at the ends by "Not Visible (0)" and "Clearly Delineated (4)." The mean difference was calculated, and a higher number indicated increased visibility.
次要结局
未报告次要终点