The effect of dehydration on retinal blood flow by optical coherence tomography(OCT)
Design
Pragmatic, community based , Randomised , without control group , experimental ( before-after ) of 31patients
Settings and conduct
31 healthy volunteers from the general population aged over 50 will be asked to refrain from eating food and water for 12 hours after explaining about the design and obtaining informed consent. After this period, OCT angiography will be performed.
Then, volunteers receive a standard serving of food and fluids (200 g of dry food including bread and cheese / 300 cc of fluid -> water + tea + milk), and again 2 hours later, the OCT will be performed in similar conditions and the results of the two measurements Will be compared.
Participants/Inclusion and exclusion criteria
Entrance conditions: age<50 , healthy participants without congenital disorders
Egress conditions: smokers , participants with congenital disorders
Intervention groups
participants should not eat and drink for 12 hours and after first measurement they should eat an standard meal
Main outcome variables
Dehydration does not reduce retinal blood flow.
General information
Reason for update
Acronym
OCT
IRCT registration information
IRCT registration number:IRCT20190505043482N1
Registration date:2019-06-08, 1398/03/18
Registration timing:registered_while_recruiting
Last update:2019-06-08, 1398/03/18
Update count:0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Zahra Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3386 9781
Email address
zsoltani_311@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-08, 1398/03/18
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dehydration on retinal blood flow, An OCT based evaluation
Public title
Effect of dehydration on retinal blood flow
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
healthy volunteers without any basis disease
age should be more than 50
Exclusion criteria:
smokers
people with congenital disorders
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Nikookari Hospital., Abbasi Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5167914165
Approval date
2019-04-27, 1398/02/07
Ethics committee reference number
IR.TBZMED.REC.1398.102
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
retinal blood flow
Timepoint
retinal blood flow measurement after 12 hours "not eating food and drinking" and 2 hours after eating and drinking an standard serving
Method of measurement
Optical Coherence Tomography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals should not eat and drink for 12 hours , then OCT angiography will done. After that participants will take an standard serving ( 200 gr food and 300 cc liquid) and after 2 hours another OCT angiography (in the same condition as past) will done and the results will compare.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikukari Hospital
Full name of responsible person
Behzad Fallahi Motlaq
Street address
Nikukari Hospital., Abbasi Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5167914165
Phone
+98 41 3386 9781
Email
zsoltani_311@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
DR. Ata Mahmoodpour
Street address
Nikukari hospital, Abbasi Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5167914165
Phone
+98 41 3386 9781
Email
zsoltani_311@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Fallahi Motlaq
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Nikookari Hospital., Abbasi Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5167914165
Phone
+98 41 3386 9781
Email
zsoltani_311@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Fallahi Motlaq
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Nikookari Hospital., Abbasi Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5167914165
Phone
+98 41 3386 9781
Email
zsoltani_311@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Fallahi Motlaq
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Nikookari Hospital., Abbasi Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5167914165
Phone
+98 41 3386 9781
Email
zsoltani_311@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available