Preoperative Topic Diclofenac as a Prevention 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.
Drug: Perioperative Diclofenac eye-drops administration
|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|
- 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.
- 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.
|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)|
Patients with diabetic retinopathy having preoperative treatment with diclofenac
|Drug: Perioperative Diclofenac eye-drops administration|
Placebo Comparator: Placebo
Control group having placebo treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694212
|Poliklinika Medic Zuljan Jukić|
|Split, Croatia, 21000|
|Principal Investigator:||Ljubo Znaor, MD PhD||Clinical Hospital Center, Split|