NCT02306031

Topical Diclofenac on Macular Thickness After Phacoemulsification

The Effect of Topical Sodium Diclofenac on Macular Thickness in Diabetic Eyes After Phacoemulsification: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Oculopathy

Interventions

Type	Name	Description
DRUG	Prescribe ARTIFICIAL TEAR	From one week before surgery, and 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
DRUG	Prescribe diclofenac sodium drop 0.1%	From one week before surgery, 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

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-06-01
• First posted: 2014-12-03
• Last updated: 2014-12-03

Locations

1 site across 1 country: Iran