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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| installation of Ketorolac Tromethamine Eye Drop | Active Comparator |
| |
| not receiving placebo | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| using of Ketorolac Tromethamine Eye Drop | Drug | using of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected visual acuity | Snellen visual acuity chart | 24 weeks after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| retinal and choroidal thickness | enhanced depth imaging optical coherence tomography (EDI-OCT) | 24 weeks after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hossien Mohammad Rabie, MD | Contact | 9822591616 | labbafi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37452330 | Derived | Mohammad-Rabei H, Sabbaghi H, Emamverdi M, Karimi S, Ramezani A, Nikkhah H, Kheiri B, Yaseri M, Sheibani K, Bahreini R. The effect of topical ketorolac tromethamine on macular thickening after phacoemulsification in diabetic patients. BMC Ophthalmol. 2023 Jul 14;23(1):320. doi: 10.1186/s12886-023-03077-y. |
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