Investigating changes in choroidal thickness and choroidal angiogenesis and investigating changes in anterior segment factors before and after consuming caffeinated and non-caffeinated beverages
Design
A clinical trial using people from the intervention group before the intervention as a control group, one-way blinding, phase 1, on 50 patients.
Settings and conduct
In this study, the selected people will drink coffee without caffeine one day and drink coffee with caffeine on another day. Imaging will also be done once before drinking coffee and then one hour, two, three and four hours after drinking coffee. Also, one-way blinding will be done and the people present in the study will not know the type of coffee used.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Eye health in routine examinations
Not using hard contact lenses in the last month
Not using soft contact lenses in the last two weeks
Personal consent to participate in the research project
Not consuming coffee at least 4 hours before attending the program
No smoking
Do not drink coffee or any caffeinated drinks while studying
Exclusion criteria:
History of systemic and ophthalmic disease
People with cardiac arrhythmia
History of hypertension, diabetes, glaucoma, uveitis
Pregnancy and breastfeeding
Taking drugs that affect the posterior and anterior segment
History of eye surgery
Intervention groups
All participants will be subjected to the intervention by drinking caffeinated and decaffeinated coffee on two days. The control group is also the people of the intervention group, which will be completely compared the day before the intervention.
Main outcome variables
Choroidal vascularity index؛ Angle-opening distance؛ Trabecular iris angle؛ Trabecular iris space area؛ Anterior chamber depth؛ Choroidal and Corneal thickness؛ Choroidal luminal and stromal thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231031059914N1
Registration date:2023-11-13, 1402/08/22
Registration timing:prospective
Last update:2023-11-13, 1402/08/22
Update count:0
Registration date
2023-11-13, 1402/08/22
Registrant information
Name
Niloofar Irandoost
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3322 5633
Email address
irandoustn4012@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Caffeine on Choroidal Thickness, Vascularization index, and Anterior Segment Parameters of the Eye in healthy population
Public title
Effect of Coffee on Eye
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ocular health in normal examination
Not using hard contact lenses in the last month
Not using soft contact lenses in the last two weeks
Personal consent to participate in the research project
Not consuming coffee at least 4 hours before attending the program
No smoking
Not drinking coffee or any caffeinated drinks during the test
Exclusion criteria:
History of systemic and ophthalmic disease
People with cardiac arrhythmia
History of hypertension, diabetes, glaucoma, uveitis
Pregnancy and breastfeeding
Taking medications that affect posterior and anterior segment of the eye
History of eye surgery
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants will be unaware of the presence or absence of caffeine in each phase of the study.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mashhad University of Medical Sciences
Street address
Qureishi Building, Daneshgah Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Approval date
2023-10-07, 1402/07/15
Ethics committee reference number
IR.MUMS.REC.1402.197
Health conditions studied
1
Description of health condition studied
Choroidal thickness changes
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Changes in anterior segment factors
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Changes in choroidal vascular index
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Choroidal vascularity index
Timepoint
Before intervention and 1, 2, 3, and 4 hours after intervention
Method of measurement
Posterior and anterior optical coherence tomography
2
Description
Angle-opening distance
Timepoint
Before intervention and 1, 2, 3, and 4 hours after intervention
Method of measurement
Posterior and anterior optical coherence tomography
3
Description
Trabecular iris angle
Timepoint
Before intervention and 1, 2, 3, and 4 hours after intervention
Method of measurement
Posterior and anterior optical coherence tomography
4
Description
Trabecular iris space area
Timepoint
Before intervention and 1, 2, 3, and 4 hours after intervention
Method of measurement
Posterior and anterior optical coherence tomography
5
Description
Anterior chamber depth
Timepoint
Before intervention and 1, 2, 3, and 4 hours after intervention
Method of measurement
Posterior and anterior optical coherence tomography
6
Description
Choroidal thickness
Timepoint
Before intervention and 1, 2, 3, and 4 hours after intervention
Method of measurement
Posterior and anterior optical coherence tomography
7
Description
Corneal thickness
Timepoint
Before intervention and 1, 2, 3, and 4 hours after intervention
Method of measurement
Posterior and anterior optical coherence tomography
8
Description
Choroidal luminal thickness
Timepoint
Before intervention and 1, 2, 3, and 4 hours after intervention
Method of measurement
Posterior and anterior optical coherence tomography
9
Description
Choroidal stromal thickness
Timepoint
Before intervention and 1, 2, 3, and 4 hours after intervention
Method of measurement
Posterior and anterior optical coherence tomography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These people are given caffeinated coffee.
Category
N/A
2
Description
Control group: These people are given decaffeinated coffee.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Al-Anbia eye hospital
Full name of responsible person
Asieh Ehsaei
Street address
Abutaleb junction, Gharani Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 9911
Fax
+98 51 3728 9911
Email
Ehsaeia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Qureshi Building, Daneshgah Street, Mashhad
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
Iman Varshovi-Jaghargh
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Optometry
Street address
Unit 8, No. 13, Hashemieh 63
City
Mashhad
Province
Razavi Khorasan
Postal code
9178175751
Phone
+98 51 3881 8761
Email
I.Varshovi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Asieh Ehsaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Optometry
Street address
Unit 7, No. 23, Mina 6, Mina Ave., Bahar 18, Sajjad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9174324401
Phone
+98 51 3884 6719
Email
Ehsaeia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Niloofar Irandoost
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Optometry
Street address
No. 2 , Shemshad alley , Bu Ali Sina street , Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413679559
Phone
+98 28 3322 5633
Email
niloofar.irandoosr@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
The non-identified information of people will be accessible to people after the publication of the article.
When the data will become available and for how long
The access period starts 3 months after the publication of the article
To whom data/document is available
The public will be allowed to access the information.
Under which criteria data/document could be used
For all scientific requests, documents can be used.
From where data/document is obtainable
Contact the following Email:
I.Varshovi@Gmail.com
What processes are involved for a request to access data/document
The request will be sent to the individual within one month after being raised in the clinical trial scientific group.