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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694212
• Other study ID #: MZJ-2106
• Status: Completed
• Phase: N/A
• First received: September 23, 2012
• Last updated: April 19, 2017
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Eye Clinic Medic Zuljan Jukic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Diseases

Intervention

Drug:
• Perioperative Diclofenac eye-drops administration

• placebo

Locations

Country	Name	City	State
Croatia	Poliklinika Medic Zuljan Jukic	Split

Sponsors (3)

Lead Sponsor	Collaborator
Eye Clinic Medic Zuljan Jukic	Clinical Hospital Center, Split, University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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