Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- visual acuity
研究概览
简要总结
Purpose: To evaluate the short-term effect of adding topical ketorolac to the management of diabetic macular edema (DME) with intravitreal bevacizumab (IVB).
Setting: Ophthalmology department of Imam Hossein and Torfe Medical Centers. Ophthalmic Epidemiology Research Center of Shahid Beheshti University of Medical Sciences Methods: In a randomized double-masked placebo-controlled crossover clinical trial, all eyes with DME with best-corrected visual acuity (BCVA) between 20/40 and 20/400 were included. They should have had at least one intravitreal anti-VEGF injection in the past 2 months. They were randomized into two groups. Both groups received two IVB injections with 6-week interval. One group received topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. The other group received the opposite medications. Best-corrected visual acuity (BCVA) and central macular thickness (CMT) evaluations were repeated at the termination of each treatment period i.e. at 6 and 12 weeks. The main outcome measure was BCVA changes in logMAR and the second outcome was CMT changes. The interim analysis of this study is presented in this report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BCVA≤20/40 and BCVA 20/400 and better
- •History of at least 1 intra-viteral bevacizumab (IVB) in the last 2 months
- •Requires 2 IVB in the next 12 weeks
- •Macular thickness >300 μm
- •NO Other eye diseases
- •Media clarity , pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
排除标准
- •hgb A1c> 8
- •high risk PDR
- •Macular edema due to a cause other than diabetic retinopathy
- •Any other ocular condition that visual acuity would not improve from resolution of edema (eg.foveal atrophy)
- •Prior treatment with intravitreal or peribulbar corticosteroid injection during last 3months
- •History of macular photocoagulation during the last 6 months
- •intraocular surgery(except cataract surgery)
- •Cataract extractionin less than 6 months ago
- •Uveitis ,NVG ,exudative AMD, HR PDR.
- •Uncontrolled glaucoma
- •Vitreomacular traction or epiretinal membrane
研究组 & 干预措施
usage of topical ketorolac in group1
usage of topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
干预措施: prescription topical ketorolac in group 1 (Drug)
usage of artificial tear in group 2
usage of artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
干预措施: prescription artificial tear in group 2 (Drug)
usage of artificial tear in group 1
usage of topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval
干预措施: prescription artificial tear in group1 (Drug)
usage of topical ketorolac in group2
usage of artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval
干预措施: prescription topical ketorolac in group 2 (Drug)
结局指标
主要结局
visual acuity
时间窗: 6 weeks
Snellen E-chart
次要结局
- Centeral macular thickness(6 weeks)
研究者
Zahra Rabbani Khah
Head of ophthalmic research center
Shahid Beheshti University of Medical Sciences