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Completed

NCT Number: NCT01694212

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.

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Key information

Conditions

Macular Edema Cardiovascular Diseases Cataract Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Lens Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poliklinika Medic Zuljan Jukić

Split, 21000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perioperative Diclofenac eye-drops administration

Drug

Placebo

Drug

Primary outcomes

  1. Change of Central Macular Thickness

    Time frame: -7, 0, 1, 7, 30, 90 days after the cataract surger

    The central macular thickness will be measured with OCT machine.

Secondary outcomes

  1. progression of diabetic retinopathy

    Time frame: -7 and 90 days after cataract surgery

    The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria

  2. IL-12 concentration

    Time frame: immediately before cataract surgery

    The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.

Sponsors and collaborators

Lead sponsor

Eye Clinic Medic Zuljan Jukic

Other

Collaborators

  • Clinical Hospital Center, Split
  • University of Zagreb

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 27, 2012
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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