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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
Ophthalmic Research Center
Tehran, Iran
visual acuity
Snellen E-chart
Time frame: 6 weeks
Centeral macular thickness
Ophtical Cohearence Tomography
Time frame: 6 weeks
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