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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01694212

Enrollment

Registered

2012-09-27

Start date

2012-10-31

Completion date

2016-12-31

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Diabetic Retinopathy, Macular Edema

Keywords

Macular edema, Cataract, Diabetic retinopathy, Anti-inflammatory agents,Non-steroidal

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.

Interventions

DRUGPerioperative Diclofenac eye-drops administration

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026