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