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Topical Diclofenac on Macular Thickness After Phacoemulsification (diclofenac)

Primary Purpose

Diabetic Oculopathy

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Prescribe ARTIFICIAL TEAR
Prescribe diclofenac sodium drop 0.1%
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Oculopathy focused on measuring diclofenac, macular thickness, phacoemulsification, OCT(Optical coherence tomography ), diabetic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Labbafinejad medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo (ARTIFICIAL TEAR)

diclofenac sodium drop

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

macular thickness changes
Optical coherence tomography (OCT)

Secondary Outcome Measures

best corrected visual acuity (BCVA) changes
LogMAR (Logarithm of the Minimum Angle of Resolution)charts

Full Information

First Posted
November 15, 2014
Last Updated
November 29, 2014
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02306031
Brief Title
Topical Diclofenac on Macular Thickness After Phacoemulsification
Acronym
diclofenac
Official Title
The Effect of Topical Sodium Diclofenac on Macular Thickness in Diabetic Eyes After Phacoemulsification: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Oculopathy
Keywords
diclofenac, macular thickness, phacoemulsification, OCT(Optical coherence tomography ), diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo (ARTIFICIAL TEAR)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
diclofenac sodium drop
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prescribe ARTIFICIAL TEAR
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Prescribe diclofenac sodium drop 0.1%
Intervention Description
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 Measure Information:
Title
macular thickness changes
Description
Optical coherence tomography (OCT)
Time Frame
preoperatively until 90 days
Secondary Outcome Measure Information:
Title
best corrected visual acuity (BCVA) changes
Description
LogMAR (Logarithm of the Minimum Angle of Resolution)charts
Time Frame
preoperatively until 90 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Labbafinejad medical center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Topical Diclofenac on Macular Thickness After Phacoemulsification

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