The Effect of Ocular Rinse Volume on Surface Irritation After Povidone-iodine Preparation for Intravitreal Injections: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Ocular Surface Disease Index
研究概览
简要总结
This is the first randomized controlled trial looking into post-injection rinse volume of standard ophthalmic eyewash and its affect on patient comfort up to 72 hours after injections.
详细描述
Purpose To evaluate whether the volume of wash out rinse after povidone iodine (PI) application for intravitreal injections (IVI) affects patients' ocular surface irritation.
Methods This was a prospective, single-masked, randomized-controlled trial consisting of 142 subjects . A total of 51, 45, and 46 patients received 3-mL, 10-mL, and 15-mL of ocular rinse respectively. Reductions in the Ocular Surface Disease Index (OSDI) and the Standardized Patient Evaluation of Eye Dryness II (SPEED II) surveys, conducted before and at 24-72 hours post-injection, were analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •choroidal neovascular membrane or cystoid macular edema requiring intravitreal injections for treatment.
排除标准
- •active ocular infection, eyelid trauma, graft versus host disease, thyroid eye disease, pregnancy.
结局指标
主要结局
Ocular Surface Disease Index
时间窗: 24-72 hours after injection
Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.
次要结局
- Standardized Patient Evaluation of Eye Dryness II(24-72 hours after injection)