Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 102
- 主要终点
- Best Corrected visual acuity
研究概览
简要总结
The aim of the study is determining the prophylactic effect of ketorolac tromethamine drop 0.5% eye drop on the functional and anatomical ocular characteristics of the diabetic patients after the phacoemulsification surgery. Cystoid macular edema (CME) is a ocular disease which the retinal thickness is increased by 30 % incidence at least or the visual acuity is decreased to 20/40 according to clinical definition. Ketorolac tromethamine is an non steroidal anti inflammatory medication which is used for treatment and Prophylactic for CME. Teh aim of this study is prophylactic effect of ketorolac tromethamine on choroidal and retinal thickness after Phacoemulsification in Diabetic Patients. In this randomized clinical trial, 102 eyes of 102 diabetic patients were included. All patients were undergone phacoemulsification surgery at Torfeh Eye Hospital between September 2015 and January 2017. To evaluate the prophylactic effect of ketorolac tromethamine topical eye drop, all cases were asked to apply it one day before the s:surgery in each 8 hours and continue it for 4 weeks after the surgery. Controls were not received placebo. All study population were examined using Snellen visual acuity chart, enhanced depth imaging optical coherence tomography (EDI-OCT). All patients were followed at 6, 12 and 24 weeks after the cataract surgery.
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 95 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic patients (type II) with cataract
- •Eligible patients at age range of 20 to 95 years old
排除标准
- •Cases with a diabetic macular edema
- •proliferative diabetic retinopathy
- •history of intravitreal injection of bevacizumab and macular photocoagulation prior three months to the cataract surgery
- •refractive errors of more than ±6 diopters
- •history of previous ocular surgery
- •ocular pathological disorders
- •history of systemic diseases
- •history of medications which have a side effect on the retinal thickness
- •patients with a follow up of less than 6 months
- •individuals with any intraoperative complications will be excluded from this study.
研究组 & 干预措施
installation of Ketorolac Tromethamine Eye Drop
干预措施: using of Ketorolac Tromethamine Eye Drop (Drug)
结局指标
主要结局
Best Corrected visual acuity
时间窗: 24 weeks after the surgery
Snellen visual acuity chart
次要结局
- retinal and choroidal thickness(24 weeks after the surgery)
研究者
Zahra Rabbani Khah
Clinical Professor
Shahid Beheshti University of Medical Sciences
