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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Cystoid Macular Edema After Phacoemulsification

Treatments: Drug: using of Ketorolac Tromethamine Eye Drop

Study type: Interventional

Funder types: Other

Identifiers

NCT03551808

96316

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 20 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

installation of Ketorolac Tromethamine Eye Drop

Active Comparator group

Treatment:

Drug: using of Ketorolac Tromethamine Eye Drop

not receiving placebo

No Intervention group