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

Not Applicable

Completed

• Conditions: Macular Edema; Cataract; Diabetic Retinopathy
• Interventions: Drug: Perioperative Diclofenac eye-drops administration; Drug: placebo

• Registration Number: NCT01694212
• Lead Sponsor: Eye Clinic Medic Zuljan Jukic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-23
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Study Start: 2012-10
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac	Perioperative Diclofenac eye-drops administration	Patients with diabetic retinopathy having preoperative treatment with diclofenac
Placebo	placebo	Control group having placebo treatment

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Poliklinika Medic Zuljan Jukić; 🇭🇷 Split, Croatia