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

May 29, 2018 updated by: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: installation of Ketorolac Tromethamine Eye Drop
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
No Intervention: not receiving placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96316

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystoid Macular Edema After Phacoemulsification

Clinical Trials on using of Ketorolac Tromethamine Eye Drop

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe