Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
- Conditions
- DME
- Interventions
- Drug: prescription topical ketorolac in group 1Drug: prescription artificial tear in group 2Drug: prescription topical ketorolac in group 2Drug: prescription artificial tear in group1
- Registration Number
- NCT04119921
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description usage of topical ketorolac in group1 prescription topical ketorolac 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. usage of artificial tear in group 2 prescription 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. usage of topical ketorolac in group2 prescription topical ketorolac 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 usage of artificial tear in group 1 prescription artificial tear 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
- Primary Outcome Measures
Name Time Method visual acuity 6 weeks Snellen E-chart
- Secondary Outcome Measures
Name Time Method Centeral macular thickness 6 weeks Ophtical Cohearence Tomography
Trial Locations
- Locations (1)
Ophthalmic Research Center
🇮🇷Tehran, Iran, Islamic Republic of