The Effect of Preoperative Topical Ketorolac 0.45% on Aqueous Cytokine Levels and Macular Thickness in Diabetic and Non Diabetic Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays
研究概览
简要总结
The purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery.
详细描述
To compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients treated with preoperative topical ketorolac tromethamine 0.45%.
To compare the macular thickness changes in diabetic and non diabetic patients treated with preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory cytokines.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic patient group
- •Type 2 diabetes mellitus with no diabetic retinopathy
- •If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
- •Listed for phacoemulsification cataract surgery
- •Non diabetic patient group
- •No history of diabetes
- •If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
- •Listed for phacoemulsification cataract surgery
排除标准
- •Presence of immune disease, local or systemic inflammation
- •Presence of retinal diseases, glaucoma
- •Previous surgical procedure on the eye
- •Intra-operative complications
研究组 & 干预措施
Diabetes mellitus patients
Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery
干预措施: Ketorolac tromethamine ophthalmic solution 0.45% (Drug)
Non diabetic patients
Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery
干预措施: Ketorolac tromethamine ophthalmic solution 0.45% (Drug)
结局指标
主要结局
Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays
时间窗: 9 months
Aqueous samples were analyzed at the same after complete samples collection.
次要结局
- Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography(9 months)
研究者
Lai Yin Peng, MD
Principal Investigator
University of Malaya