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Trial record 8 of 453 for:    DICLOFENAC

Topical Diclofenac on Macular Thickness After Phacoemulsification (diclofenac)

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ClinicalTrials.gov Identifier: NCT02306031
Recruitment Status : Unknown
Verified November 2014 by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : December 3, 2014
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, 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.

Condition or disease Intervention/treatment Phase
Diabetic Oculopathy Drug: Prescribe ARTIFICIAL TEAR Drug: Prescribe diclofenac sodium drop 0.1% Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Topical Sodium Diclofenac on Macular Thickness in Diabetic Eyes After Phacoemulsification: A Randomized Controlled Trial
Study Start Date : June 2013
Actual Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Placebo Comparator: placebo (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.
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

Active Comparator: diclofenac sodium drop
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.
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




Primary Outcome Measures :
  1. macular thickness changes [ Time Frame: preoperatively until 90 days ]
    Optical coherence tomography (OCT)


Secondary Outcome Measures :
  1. best corrected visual acuity (BCVA) changes [ Time Frame: preoperatively until 90 days ]
    LogMAR (Logarithm of the Minimum Angle of Resolution)charts



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 >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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306031


Locations
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Iran, Islamic Republic of
Labbafinejad medical center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

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Responsible Party: Zahra Rabbani Khah, Clinical Professor, Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02306031     History of Changes
Other Study ID Numbers: 88108
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: November 2014
Keywords provided by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences:
diclofenac
macular thickness
phacoemulsification
OCT(Optical coherence tomography )
diabetic
Additional relevant MeSH terms:
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Diclofenac
Eye Diseases
Lubricant Eye Drops
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ophthalmic Solutions
Pharmaceutical Solutions