Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Change of Central Macular Thickness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Diclofenac
Patients with diabetic retinopathy having preoperative treatment with diclofenac
Intervention: Perioperative Diclofenac eye-drops administration (Drug)
Placebo
Control group having placebo treatment
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
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
- progression of diabetic retinopathy(-7 and 90 days after cataract surgery)
- IL-12 concentration(immediately before cataract surgery)
Investigators
Ljubo Znaor
Ophthalmologist
Clinical Hospital Center, Split