DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Topical Diclofenac on Macular Thickness After Phacoemulsification

Information source: Shahid Beheshti Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Oculopathy

Intervention: Prescribe ARTIFICIAL TEAR (Drug); Prescribe diclofenac sodium drop 0.1% (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Shahid Beheshti Medical University


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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: macular thickness changes

Secondary outcome: best corrected visual acuity (BCVA) changes


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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 >260ยต 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.

Locations and Contacts

Labbafinejad medical center, Tehran, Iran, Islamic Republic of
Additional Information

Starting date: June 2013
Last updated: November 29, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017