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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

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.

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Detailed Description

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Conditions

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Macular Edema Cataract Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diclofenac

Patients with diabetic retinopathy having preoperative treatment with diclofenac

Group Type EXPERIMENTAL

Perioperative Diclofenac eye-drops administration

Intervention Type DRUG

Placebo

Control group having placebo treatment

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Perioperative Diclofenac eye-drops administration

Intervention Type DRUG

placebo

Intervention Type DRUG

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

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No