Optimizing Preoperative Disinfection of Eyes
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Conjunctival bacterial culture
研究概览
简要总结
Topical povidone-iodine (PI) is widely used as ocular antiseptic before and after surgery. The standard dose of 5% PI is however, associated with ocular irritation. We therefore want to test if a lower concentration of PI can be similarly efficacious in reducing bacterial growth while reducing ocular irritation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients remitted to intravitreal injections at St. Olavs hospital.
- •Patients competent to give written consent
排除标准
- •Infectious disease
- •Known epitheliopathy
- •Contact lens wear
- •Use of prescription ophthalmic medications
研究组 & 干预措施
Povidone-Iodine 0.3 %
A tampon is soaked in diluted PI 0.3% and placed on the inside of the lower eyelid of one eye, where it will release iodine molecules for 20 minutes before being removed.
干预措施: Povidone-Iodine 0.3% (Drug)
Povidone-Iodine 5 %
Eye drops of 5% PI is the standard disinfection before eye surgery. The drops will be dripped in one eye and allowed to work for 2 minutes.
干预措施: Povidone-Iodine 5% (Drug)
结局指标
主要结局
Conjunctival bacterial culture
时间窗: 1 hour. Bacterial sample is taken before and immediately after disinfection
Change in colony-forming units (CFU) per milliliter (ml)
次要结局
- Patient pain score(During disinfection and after 1 hour when the anesthetic no longer is effective)
- Ocular staining score (OSS)(1 hour after disinfection)