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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01694212
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : April 20, 2017
Clinical Hospital Center, Split
University of Zagreb
Information provided by (Responsible Party):
Ljubo Znaor, Clinical Hospital Center, Split

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Macular Edema Cataract Diabetic Retinopathy Drug: Perioperative Diclofenac eye-drops administration Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy
Study Start Date : October 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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.

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01694212

Poliklinika Medic Zuljan Jukić
Split, Croatia, 21000
Sponsors and Collaborators
Eye Clinic Medic Zuljan Jukic
Clinical Hospital Center, Split
University of Zagreb
Principal Investigator: Ljubo Znaor, MD PhD Clinical Hospital Center, Split

Responsible Party: Ljubo Znaor, Ophthalmologist, Clinical Hospital Center, Split Identifier: NCT01694212     History of Changes
Other Study ID Numbers: MZJ-2106
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Ljubo Znaor, Clinical Hospital Center, Split:
Macular edema
Diabetic retinopathy
Anti-inflammatory agents,Non-steroidal

Additional relevant MeSH terms:
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action