The Effect of conventional antiglaucoma medications; such as Timolol, Brimonidin, Latanoprost and Dorzolamide Eye Drops on Prepapillary and Optic Nerve Head Circulation
Quantitative evaluation of vascular dystonia (VD) and surface area of perfusion area of ONH and papillary after administration of common antiglaucoma drugs in healthy young people
Design
The use of non-recurrent sampling based on the purpose of healthy young people after entering into an acute satisfaction is included in the study. After recording the demographic data, all subjects undergoing an ophthalmic examination including vision, intraocular pressure, fundus examination. Subjects were then randomly assigned to one of the four intervention groups randomly (using closed envelopes) and received one of four topical topolymuloid drops, topical dopozlamide drops, topical bimonidine drops, or latanoprost drops in their right eye by the resident's eye. they do. The left eye control group is the same as those who receive the drug.
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
A quantitative evaluation of vascular density (VD) and level of perfusion area of ONH and papillary aphidia following the administration of common antiglaucoma drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190405043168N1
Registration date:2019-09-06, 1398/06/15
Registration timing:registered_while_recruiting
Last update:2019-09-06, 1398/06/15
Update count:0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Marzieh Ghannad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 9536
Email address
anaghannad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of conventional antiglaucoma medications; such as Timolol, Brimonidin, Latanoprost and Dorzolamide Eye Drops on Prepapillary and Optic Nerve Head Circulation
Public title
The Effect of conventional antiglaucoma medications; such as Timolol, Brimonidin, Latanoprost and Dorzolamide Eye Drops on Prepapillary and Optic Nerve Head Circulation
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious Consciousness
Normal Ocular Examination
Normal IOP
Exclusion criteria:
Diabetes and hypertension and family history of high pressure of the eye
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
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, volunteer healthy volunteers were randomly assigned to one of the four intervention groups. For each group, one of four topical timolol drugs, dorzolamid drops, topical bimonidine drops, and topical latannoprost drops were used in the right eye.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The four drugs used by one of the physicians are initially called abbreviated, and thus the patient, the perimeter papillary permeate optometry and measurement gauge, and the statistic consultant who has the purpose of analyzing the data, are unaware of the type of drops. After the data analysis is completed, the nature of the drug groups is determined
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Azadi Square, University of Pardis, Faculty of Medicine, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
1397-09-13, 777/01/-188
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.657
Health conditions studied
1
Description of health condition studied
Evaluation of the effect of anti-glaucoma drugs on the blood flow of the optic nerve head
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of the effect of anti-glaucoma drugs on the blood flow of the optic nerve head
Timepoint
Before taking the medication and at the time of the peak of the medication
Method of measurement
OCTA optivue Device
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
Marzieh Ghannad
Street address
Khatam Al anbia hospital, Gharani Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1400
Email
anaghannad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeid Eslami
Street address
ghoreyshi building, daneshgah ave
City
mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3845 2474
Email
ramresearch@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
saeed shokoohi rad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Gharani ave , Khatam Al-Anbia hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
shokoohirads@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
marzieh ghannad
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
anaghannad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Ghannad
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
919596591
Phone
+98 51 3828 1401
Email
anaghannad@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. ghannad
What processes are involved for a request to access data/document
official request should send to khatam al anbia hospital