Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy

April 19, 2017 updated by: Ljubo Znaor, Eye Clinic Medic Zuljan Jukic

Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy

Diabetes has many negative effects on patients' general health. Among many other consequences it speeds up the cataract formation and that is why diabetic patients need cataract surgery very often. The known side effect of cataract surgery even in otherwise healthy patients is postoperative edema of the back of the eye (what causes decrease of vision), which has greater incidence especially in patients who have diabetic eye problems. The cause of that might be the intraocular inflammation which was previously demonstrated to be significantly more prominent in patients with untreated diabetic eye problems. Therefore we will examine if the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the formation of the edema of the back of the eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • Poliklinika Medic Zuljan Jukić

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

60 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of nonproliferative diabetic retinopathy
  • presence of the cataract (LOCS 2-3)

Exclusion Criteria:

  • other chronic or acute eye diseases
  • hypersensitivity to any component of the diclofenac eye-drops patients on oral anticoagulant therapy
  • allergy to salycilates

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diclofenac
Patients with diabetic retinopathy having preoperative treatment with diclofenac
Drug: Perioperative Diclofenac eye-drops administration
PLACEBO_COMPARATOR: Placebo
Control group having placebo treatment
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Central Macular Thickness
Time Frame: -7, 0, 1, 7, 30, 90 days after the cataract surger
The central macular thickness will be measured with OCT machine.
-7, 0, 1, 7, 30, 90 days after the cataract surger

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression of diabetic retinopathy
Time Frame: -7 and 90 days after cataract surgery
The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria
-7 and 90 days after cataract surgery
IL-12 concentration
Time Frame: immediately before cataract surgery
The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.
immediately before cataract surgery

Collaborators and Investigators

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

Sponsor

Eye Clinic Medic Zuljan Jukic

Collaborators

University of Zagreb
Clinical Hospital Center, Split

Investigators

  • Principal Investigator: Ljubo Znaor, MD PhD, Clinical Hospital Center, Split

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

October 1, 2012

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

September 23, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (ESTIMATE)

September 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZJ-2106

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.

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