A Comparison Between the Ocular Surface of Different Concentrations of Benzalkonium Chloride Preservative in Postoperative Topical Medications After Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- OSDI
研究概览
简要总结
study the effect of different concentrations of benzalkonium chloride on the ocular surface of non-dry-eyed patients post cataract surgery.
详细描述
60 eyes of will be included in this study.
- 20 eyes will receive regular Tobradex 0.1mg/ml BAK 5 times per day (Group 1).
- 20 eyes will receive Dexathalm multidose 0.05mg/ml BAK 5 times per day (Group 2).
- 20 eyes will receive single dose unit Dexathalm NO BAK 5 times per day (Group 3).
Preoperative assessment:
All selected patients will receive thorough explanation of the study design and aims, an informed consent will be obtained from all patients.
Tear break up time (TBUT) will be measured non-invasively by Ocular Surface analyzer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing uncomplicated cataract surgery
- •Cataract grade: (LOCSIII): NO2NC2,C3,P2
排除标准
- •Preoperative non-invasive TBUT<10 seconds. Patients who have rheumatoid arthritis or autoimmune diseases affecting corneal surface.
- •Involutional entropion or ectropion preoperative Postoperative significant corneal edema requiring medication.
研究组 & 干预措施
Group A
20 eyes received single dose unit Dexathalm containing: actives: In 1ml: Dexamethason 1mg and Netilimicin 3mg, without preservatives 5 times per day.
干预措施: Dexamethasone, tobramycin, netilimicin (Drug)
Group B
20 eyes received regular Tobradex eye drops containing actives: In 1 ml: tobramycin 3 mg and dexamethasone 1 mg, preservative: 0.1mg of BAK per ml 5 times per day.
干预措施: Dexamethasone, tobramycin, netilimicin (Drug)
Group C
20 eyes received Dexathalm multi-dose containing actives: In 1ml: Dexamethasone 1mg and Netilimicin 3mg, preservatives: 0.05mg of BAK per ml 5 times per day.
干预措施: Dexamethasone, tobramycin, netilimicin (Drug)
结局指标
主要结局
OSDI
时间窗: preoperative and 1 month postoperative
ocular surface disease index
MG loss
时间窗: preoperative and 1 month postoperative
meibomian gland loss
TMH
时间窗: preoperative and 1 month postoperative
Tear meniscus Height
NBUT
时间窗: preoperative and 1 month postoperative
non invasive tear break up time
次要结局
未报告次要终点
研究者
Amnah Ayman
AAyman
Kasr El Aini Hospital