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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystoid Macular Edema After Phacoemulsification

Intervention / Treatment
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* Drug: using of Ketorolac Tromethamine Eye Drop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patients (type II) with cataract Eligible patients at age range of 20 to 95 years old Exclusion Criteria: Cases with a diabetic macular edema proliferative diabetic retinopathy history of intravitreal injection of bevacizumab and macular photocoagulation prior three months to the cataract surgery glaucoma refractive errors of more than ±6 diopters history of previous ocular surgery ocular pathological disorders history of systemic diseases history of medications which have a side effect on the retinal thickness patients with a follow up of less than 6 months individuals with any intraoperative complications will be excluded from this study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: installation of Ketorolac Tromethamine Eye Drop<br> | Drug: using of Ketorolac Tromethamine Eye Drop<br>* using of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery<br>|
| No Intervention: not receiving placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected visual acuity | Snellen visual acuity chart | 24 weeks after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal and choroidal thickness | enhanced depth imaging optical coherence tomography (EDI-OCT) | 24 weeks after the surgery |