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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usage of topical ketorolac in group1 | Active Comparator | 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 | Active Comparator | 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. |
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| usage of artificial tear in group 1 | Active Comparator | 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 topical ketorolac in group2 | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prescription topical ketorolac in group 1 | Drug | topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. |
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| Measure | Description | Time Frame |
|---|---|---|
| visual acuity | Snellen E-chart | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Centeral macular thickness | Ophtical Cohearence Tomography | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Center | Tehran | Iran |
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| prescription artificial tear in group 2 | Drug | artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval. |
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| prescription topical ketorolac in group 2 | Drug | artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval. |
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| prescription artificial tear in group1 | Drug | topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. |
|