Back to resultsPreoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy
Primary Purpose
Macular Edema, Cataract, Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Perioperative Diclofenac eye-drops administration
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Macular Edema focused on measuring Macular edema, Cataract, Diabetic retinopathy, Anti-inflammatory agents,Non-steroidal
Eligibility 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
Sites / Locations
- Poliklinika Medic Zuljan Jukić
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diclofenac
Placebo
Arm Description
Patients with diabetic retinopathy having preoperative treatment with diclofenac
Control group having placebo treatment
Outcomes
Primary Outcome Measures
Change of Central Macular Thickness
The central macular thickness will be measured with OCT machine.
Secondary Outcome Measures
progression of diabetic retinopathy
The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria
IL-12 concentration
The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.
Full Information
NCT ID
NCT01694212
First Posted
September 23, 2012
Last Updated
April 19, 2017
Sponsor
Eye Clinic Medic Zuljan Jukic
Collaborators
Clinical Hospital Center, Split, University of Zagreb
1. Study Identification
Unique Protocol Identification Number
NCT01694212
Brief Title
Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye Clinic Medic Zuljan Jukic
Collaborators
Clinical Hospital Center, Split, University of Zagreb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Cataract, Diabetic Retinopathy
Keywords
Macular edema, Cataract, Diabetic retinopathy, Anti-inflammatory agents,Non-steroidal
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac
Arm Type
Experimental
Arm Description
Patients with diabetic retinopathy having preoperative treatment with diclofenac
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control group having placebo treatment
Intervention Type
Drug
Intervention Name(s)
Perioperative Diclofenac eye-drops administration
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change of Central Macular Thickness
Description
The central macular thickness will be measured with OCT machine.
Time Frame
-7, 0, 1, 7, 30, 90 days after the cataract surger
Secondary Outcome Measure Information:
Title
progression of diabetic retinopathy
Description
The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria
Time Frame
-7 and 90 days after cataract surgery
Title
IL-12 concentration
Description
The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.
Time Frame
immediately before cataract surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ljubo Znaor, MD PhD
Organizational Affiliation
Clinical Hospital Center, Split
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poliklinika Medic Zuljan Jukić
City
Split
ZIP/Postal Code
21000
Country
Croatia
12. IPD Sharing Statement
Learn more about this trial
Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy
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