Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface As Antiseptic for Anti Vascular Endothelial Growth Factor Intravitreal Injections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Tear breaking rupture
研究概览
简要总结
Objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-VEGF intravitreal injection
详细描述
Randomized, prospective clinical trial. One group was intervened with povidone-iodine at 5% and the other at 1% as antiseptic for anti-VEGF intravitreal injection. Each patient was evaluated before and after the injection of anti-VEGF for tear break up time, bulbar redness and ocular surface satining with fluorescein. Pain perception was also evaluated 15 minutes after the injection and 48 hours after.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Patients did not know which percentage of povidone-iodine was utilized during their injection.
Tear breaking time and bulbar redness were automized results by Keraatopgrah. Oxford scale pre and post injection was staged by an investigator that did not know the group in which the patient was.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having anti-VGEF intravitreal injection scheduled
- •Informed consent signed
排除标准
- •Under 45 years
- •Opacity that prevents ophthalmological evaluation and fixation
- •Patients with severe dry eye
- •Patients with signs of infection on the ocular surface
- •Allergy to iodine
- •Pregnancy
结局指标
主要结局
Tear breaking rupture
时间窗: Change from baseline measured to 15 minutes post-injection
NIKBUT was measured with Keratopgraph before and after intravitreal injection
Bulbar redness
时间窗: Change from baseline measured to 15 minutes post-injection
Bulbar redness was measured with Keratopgraph before and after intravitreal injection
次要结局
- Oxford scale(Change from baseline measured to 15 minutes post-injection)
- Pain analog scale(Change from baseline measured to 15 minutes post-injection)
研究者
José Gerardo García Aguirre
Retina Adjunct
Asociación para Evitar la Ceguera en México