Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 主要终点
- Patient Comfort
研究概览
简要总结
- Is to assess the efficacy of preoperative disinfection with chlorohexidine and povidone iodine in different concentrations separately .
- Is to compare the efficacy of chlorohexidine to povidone iodine.
- Compare patient comfort after instillation of each disinfectant .
- To find which disinfectant is more effective tolerated and more safe for use .
详细描述
Methods: This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). . Prior to sugery patients who meet inclusion criteria will be identified and informed consent will be obtained. Study personnel will obtain two samples one from conjunctival sac and th other from skin around the eye. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% - 2.5% or AC 0.1%- 0.05% and the second eye will receive the other agent. One minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the Wong-Baker (smiley face) rating scale. After 15 minutes the second swabs will be taken in the same manner as the first swabs. . On post-operative day three, study personnel will meet the patient and ask to rate the pain in each eye using the same verbal numerical rating scale and to perform slit lamb examination for any complication.
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)
盲法说明
The participant will be masked to which drug they receive, the investigator performing the analysis will also be masked
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current patient of the Assiute University Hospital arranged for ophthamic surgery
- •Age greater than 12.
排除标准
- •Documented allergy to PI or AC
- •Current diagnosis of infectious keratitis
- •History of unilateral contact lens wear in the past 30 days
- •Current unilateral use of prescription eye drops.
研究组 & 干预措施
Povidine-Iodine
patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye before operation
干预措施: Povidone-Iodine (Drug)
chlorhexidine
patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye before operation
干预措施: Chlorhexidine (Drug)
结局指标
主要结局
Patient Comfort
时间窗: day three post operative
Patient Comfort using the Wong Baker FACES Pain Scale \[Scale: 0(No pain) - 10 (Worst Pain)\]
次要结局
- Culture of conjunctiva for bacteria(7 days)
- Patient Comfort(I minute after disinfectant drop instilled)
研究者
Asmaa mohammed mostafa
Asmaa Mohamed Mostafa
Assiut University