Evaluation of the effect of antiglaucoma medications on choroidal thickness
Design
Healthy young volunteers randomly assigned to four groups(Timolol, Dorzolamide, Brimonidine, Latanoprost). name of each medication written on a card by a codename and the participant and operator would NOT know the real name of drug.drug instilled the right eye and placebo(artificial tear) instilled in the left eye. choroidal thickness would measure before and after 2 hours later for Timolol, Dorzolamide, Brimonidine and 12 hours later for Latanoprost by EDI-OCT Heidelburg . measurement in the center , 500 mic superior , inferior , nasal and temporal to fovea .
participants , operators and data analyzer are all blinded .
Settings and conduct
Khatam Al Anbia hospital
Participants/Inclusion and exclusion criteria
Healthy young volunteers age 20-40
Intervention groups
Healthy young volunteers randomly assigned to four group
topical antiglaucoma medications : Timolol, Dorzolamide, Brimonidine, Latanoprost
Main outcome variables
Choroidal layer thickness before medication and at the peak of drug effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180203038597N1
Registration date:2018-03-10, 1396/12/19
Registration timing:retrospective
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Sadeq Ghafarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 5955
Email address
ghafarians@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
empty
Scientific title
Evaluation the effect of antiglaucoma medications on choroidal layer thickness in healthy young volunteers
Public title
Effect of antiglaucoma medications on choroidal thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy young patients
Exclusion criteria:
History of ocular disease
Allergy to antiglaucoma medications
Pregnancy and breastfeeding
Age
From 20 years old to 40 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Volunteers choose one card randomly from the cards with written name of medication by a code. patient and operator dont know the medication name
Blinding (investigator's opinion)
Double blinded
Blinding description
Four groups of medications renamed to a codename by one of physicians. volunteers & optometrists and data analyzer would be blinded. After analysis of data the real name of drugs will defined.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University od Medical Sciences
Street address
Azadi Square , Ferdowsi University
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
IRMUMS.fmREC.1395.118
Health conditions studied
1
Description of health condition studied
choroidal thickness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Choroidal thickness
Timepoint
Before medication instillation and at the peak of effect
Method of measurement
Heidelburg EDI OCT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: right eye of volunteers randomly assigned to one of antiglaucoma drugs
Category
Treatment - Drugs
2
Description
Control group: artificial tear instilled in the left eye of participants
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbia hospital
Full name of responsible person
Sadeq Ghafarian
Street address
Khatam Al anbia hospital, Gharani Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1400
Email
ghafarians@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shoeibi Nasser
Street address
Gharani ave , Khatam Al-Anbia hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
shoeibin@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nasser Shoeibi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Khatam-al-Anbia Hospital - Gharani ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
shoeibin@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sadeq Ghafarian
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Khatam Al-Anbia Hospital – Gharani ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
ghafarians@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sadeq Ghafarian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Khatam Al-Anbia Hospital – Gharani ave
City
Mashhad
Province
Razavi Khorasan
Postal code
919596591
Phone
+98 51 3828 1401
Email
ghafarians@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all of data would be accessible
When the data will become available and for how long
6 month after publish of results
To whom data/document is available
researchers in academic institutes
Under which criteria data/document could be used
there would no restrictions
From where data/document is obtainable
Khatam Al-Anbia Hospital – Gharani ave - Dr. ghafarian
What processes are involved for a request to access data/document
official request should send to khatam al anbia hospital