To determine the effect of topical ketorolac on diabetic macular edema
Design
This is a phase 3 clinical trial that is performed on 60 patients with diabetic macular edema.
Settings and conduct
This study is carried out at Kowsar Hospital in Sanandaj, Iran.
Participants/Inclusion and exclusion criteria
History of cataract surgery and vitrectomy, history of laser therapy of Avastin injection, HbA1C Instability, Sensitivity to the NSAIDs (NSAIDs or Aspirine-induced Asthma), Pregnancy, Severe retinopathy and active PDR, Retinal disorders (VR-traction,...)
Intervention groups
"intervention group": A group of patients who received the topical Ketorolac were considered as intervention group.
"Control group": A group of patients who received the Artificial Tears were considered as control group.
Main outcome variables
Change in macular edema, change in visual activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038350N2
Registration date:2018-09-25, 1397/07/03
Registration timing:registered_while_recruiting
Last update:2018-09-25, 1397/07/03
Update count:0
Registration date
2018-09-25, 1397/07/03
Registrant information
Name
Khaled Rahmani
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3312 5880
Email address
khaledrahmani111@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-20, 1397/02/30
Expected recruitment end date
2018-12-30, 1397/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Topical Ketorolac on Diabetic Macular Edema
Public title
The Effect of Topical Ketorolac on Diabetic Macular Edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Diabetic Macular Edema
Age more than 18 years
Exclusion criteria:
History of cataract surgery and vitrectomy
history of laser therapy of Avastin injection
HbA1C Instability
Sensitivity to the NSAIDs (NSAIDs or Aspirine-induced Asthma)
Pregnancy
Severe retinopathy and active PDR
Retinal disorder( VR-traction,...)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conducted based on formation of permuted block randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since most of the outcomes in this study are objective outcomes and measured by standard devices, only patients will be blinded to receiving the drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd. Kurdistan University Of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2018-07-08, 1397/04/17
Ethics committee reference number
IR.MUK.REC.1396.297
Health conditions studied
1
Description of health condition studied
Diabetic Macular Edema
ICD-10 code
E08.339
ICD-10 code description
Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema
Primary outcomes
1
Description
Any changes in Macular Edema
Timepoint
Before intervention and one month after treatment initiation.
Method of measurement
Optical Coherence Tomography (OCT)
Secondary outcomes
1
Description
Any changes in visual Acuity
Timepoint
Before intervention and one month after treatment
Method of measurement
Snellen Chart
Intervention groups
1
Description
Intervention group: Group who receive Topical Ketorolac
Category
Treatment - Drugs
2
Description
Control group: Group who receive artificial tears
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kawsar educational hospital
Full name of responsible person
Ghazal Kamali
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Fax
+98 87 3366 4643
Email
Dr.kamali.maryan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Rezaei
Street address
Kurdistan University of Medical Sciences, Sanandaj, Pasdaran Blvd,
City
Sanandaj
Province
Kurdistan
Postal code
6616797161
Phone
+98 87 3366 4653
Email
f.razaee@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khaled Rahmani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Kurdistan University of Medical Sciences, Sanandaj, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3366 4673
Email
khaledrahmani111@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ghazal Kamali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Fax
+98 87 3396 4643
Email
khaledrahmani111@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Khaled Rahmani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Fax
+98 87 3396 4643
Email
khaledrahmani111@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
In case of publisher journal request, data would be sent to the journal.
When the data will become available and for how long
During the publication of paper and 6 months after publish
To whom data/document is available
Editor of the journal that publish the paper and academic researchers with permission of correspondence author
Under which criteria data/document could be used
Data can only used to meta analysis with permission of correspondence author
From where data/document is obtainable
The correspondence author of the study
What processes are involved for a request to access data/document