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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Clinical Hospital Center, Split
University of Zagreb
Information provided by (Responsible Party):
Ljubo Znaor, Clinical Hospital Center, Split
ClinicalTrials.gov Identifier:
NCT01694212
First received: September 23, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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 Intervention
Macular Edema
Cataract
Diabetic Retinopathy
Drug: Perioperative Diclofenac eye-drops administration
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Eye Clinic Medic Zuljan Jukic:

Primary Outcome Measures:
  • Change of Central Macular Thickness [ Time Frame: -7, 0, 1, 7, 30, 90 days after the cataract surger ] [ Designated as safety issue: No ]
    The central macular thickness will be measured with OCT machine.


Secondary Outcome Measures:
  • progression of diabetic retinopathy [ Time Frame: -7 and 90 days after cataract surgery ] [ Designated as safety issue: No ]
    The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria

  • IL-12 concentration [ Time Frame: immediately before cataract surgery ] [ Designated as safety issue: No ]
    The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694212

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

No publications provided

Responsible Party: Ljubo Znaor, Ophthalmologist, Clinical Hospital Center, Split
ClinicalTrials.gov Identifier: NCT01694212     History of Changes
Other Study ID Numbers: MZJ-2106
Study First Received: September 23, 2012
Last Updated: September 26, 2012
Health Authority: Croatia: Ethics Committee

Keywords provided by Eye Clinic Medic Zuljan Jukic:
Macular edema
Cataract
Diabetic retinopathy
Anti-inflammatory agents,Non-steroidal

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

ClinicalTrials.gov processed this record on July 24, 2014