Topical Diclofenac on Macular Thickness After Phacoemulsification

Phase 2

• Conditions: Diabetic Oculopathy
• Interventions: Drug: Prescribe ARTIFICIAL TEAR; Drug: Prescribe diclofenac sodium drop 0.1%

• Registration Number: NCT02306031
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens implantation surgery have enrolled. Fifty four eyes have received the conventional postoperative care with steroid drop, whereas the other group (54 eyes) have given a preoperative diclofenac drop four times daily in addition to steroid drop and continued six weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT) preoperatively and days 1, 30, and 90.The outcome measures including best corrected visual acuity (BCVA) and OCT findings were compared in and between both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-06
• Status Verified: 2014-11
• Study First Submitted: 2014-11-15
• Study First Submitted QC: 2014-11-29
• Last Update Submitted: 2014-11-29
• Study First Posted: 2014-12-03
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Diabetic patients with non-proliferative diabetic retinopathy that were candidate for phacoemulsification and intraocular lens implantation

Exclusion Criteria

• Eyes with clinically significant macular edema based on the ETDRS(Early Treatment Diabetic Retinopathy Study) study and/or central macular thickness >260µ were not included. Neither did we include the eyes with other accompanying diseases affecting the macula or eyes with history of previous retinal laser photocoagulation or intraocular surgery.
• Eyes with severe cataract that preclude performing an acceptable quality optical coherence tomography (OCT) were not enrolled either.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo (ARTIFICIAL TEAR)	Prescribe ARTIFICIAL TEAR	control group received artificial tear (Sina Darou Laboratories Company, Tehran, Iran) as a placebo every 6 hours. Theses drops continued up to 6 weeks with the same dose after operations.
diclofenac sodium drop	Prescribe diclofenac sodium drop 0.1%	case group received diclofenac sodium drop 0.1% (Sina Darou Laboratories Company, Tehran, Iran) every 6 hours.. Theses drops continued up to 6 weeks with the same dose after operations.

Primary Outcome Measures

Name	Time	Method
macular thickness changes	preoperatively until 90 days	Optical coherence tomography (OCT)

Secondary Outcome Measures

Name	Time	Method
best corrected visual acuity (BCVA) changes	preoperatively until 90 days	LogMAR (Logarithm of the Minimum Angle of Resolution)charts

Trial Locations

Locations (1)

Labbafinejad medical center; 🇮🇷 Tehran, Iran, Islamic Republic of