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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy

Conditions
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Macular Edema, Cataract, Diabetic Retinopathy

Intervention / Treatment
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* Drug: Perioperative Diclofenac eye-drops administration
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac<br>Patients with diabetic retinopathy having preoperative treatment with diclofenac | Drug: Perioperative Diclofenac eye-drops administration<br> <br> |
| Placebo Comparator: Placebo<br>Control group having placebo treatment | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Diabetic retinopathy, Anti-inflammatory agents,Non-steroidal, Macular edema