NCT03551808

Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Years – 95 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cystoid Macular Edema After Phacoemulsification

Interventions

Type	Name	Description
DRUG	using of Ketorolac Tromethamine Eye Drop	using of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-06-01
• Completion: 2018-06-01
• First posted: 2018-06-11
• Last updated: 2018-06-11

Locations

1 site across 1 country: Iran