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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: June 1, 2017

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: installation of Ketorolac Tromethamine Eye Drop
  • No Intervention: not receiving placebo

Clinical Trial Outcome Measures

Primary Measures

  • Best Corrected visual acuity
    • Time Frame: 24 weeks after the surgery
    • Snellen visual acuity chart

Secondary Measures

  • retinal and choroidal thickness
    • Time Frame: 24 weeks after the surgery
    • enhanced depth imaging optical coherence tomography (EDI-OCT)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shahid Beheshti University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zahra Rabbani Khah, Clinical Professor – Shahid Beheshti University of Medical Sciences
  • Overall Contact(s)
    • Hossien Mohammad Rabie, MD, 9822591616, labbafi@hotmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.