Effect of Caffeine on Ocular Circulation in High Myopes
Primary Purpose
High Myopia, Choroid
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Caffeine
Vitamin E
Sponsored by
About this trial
This is an interventional diagnostic trial for High Myopia focused on measuring High Myopia, Caffeine, Choroidal Thickness, Choroidal Volume, Optical Coherence Tomography, Optical Coherence Tomography Angiography
Eligibility Criteria
Inclusion Criteria:
- Refractive error should be at least -6 Diopters or lower (spherical equivalent)
- Best corrected visual acuity of at least 6/6
- Non-smoker
Exclusion Criteria:
- Diagnosed with any ocular diseases and systemic diseases
Sites / Locations
- School of optometry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Caffeine
Vitamin E
Arm Description
To determine the effect of caffeine on ocular circulation in high myopes by consuming 200 mg caffeine capsule
To determine the effect of caffeine on ocular circulation in high myopes by consuming and 200 International Unit vitamin E control capsule, as control
Outcomes
Primary Outcome Measures
Choroidal thickness
Choroidal thickness measured by the optical coherence tomography
Secondary Outcome Measures
Retinal vessel density
Superficial retinal vessel density measured by OCTA
Full Information
NCT ID
NCT03294967
First Posted
September 20, 2017
Last Updated
July 27, 2020
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT03294967
Brief Title
Effect of Caffeine on Ocular Circulation in High Myopes
Official Title
Effect of Caffeine on Ocular Circulation in High Myopes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the effect of caffeine on ocular circulation by using Optical Coherence Tomography and Optical Coherence Tomography Angiography. This study will evaluate blood supply to the inner and outer retina after consumption of 200mg caffeine capsule, in particular its effect in high myopes.
Detailed Description
Caffeine could cause vasoconstriction. Previous studies revealed a reduction of retinal blood vessels diameter, a decrease in macular blood flow, and a decrease in blood velocity of optic nerve. Research devices, such as laser speckle tissue circulation analyzer and blue field simulation technique, were used in previous studies.
With an advancement of technology such as optical coherence tomography (OCT), choroidal thickness can be measured, which indicates blood supply to outer retina. In addition, superficial retinal vasculature can be measured using optical coherence tomography angiography (OCTA).
Previous studies found that subfoveal choroidal thickness declined with increase in myopia. A negative association between subfoveal choroidal thickness and axial length was also found. A recent study found a negative association between retinal vessel density with axial length in Chinese myopes using OCTA. Therefore, caffeine consumption may further make high myopes prone to ocular diseases development due to poor ocular circulation.
The current study will use OCTA to measure the superficial retinal vasculature and OCT to measure choroidal thickness and choroidal volume of high myopes after consumption of caffeine capsule.
Statistical analysis
Normality of data will be assessed. The effect of caffeine on choroidal thickness, choroidal volume, vessel density, and perfusion density of superficial retinal layers will be analysed using repeated-measures ANOVA (co-variates) to compare baseline data and that after caffeine consumption at various time points. If significant difference is obtained, post hoc tests will be conducted to compare results from various time points with the baseline data. Difference between different age groups will be compared using unpaired t-test or Mann Whitney test, as appropriate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia, Choroid
Keywords
High Myopia, Caffeine, Choroidal Thickness, Choroidal Volume, Optical Coherence Tomography, Optical Coherence Tomography Angiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This will be a crossover study. Each subject is required to consume 200mg caffeine capsule and 200IU vitamin E control capsule, as control, in two different visits. The two visits will be randomized, with a washout period of at least one week.
Masking
Participant
Masking Description
Participants will not see the label of the capsule.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caffeine
Arm Type
Active Comparator
Arm Description
To determine the effect of caffeine on ocular circulation in high myopes by consuming 200 mg caffeine capsule
Arm Title
Vitamin E
Arm Type
Placebo Comparator
Arm Description
To determine the effect of caffeine on ocular circulation in high myopes by consuming and 200 International Unit vitamin E control capsule, as control
Intervention Type
Dietary Supplement
Intervention Name(s)
Caffeine
Intervention Description
As in group descriptions
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Intervention Description
As in group descriptions
Primary Outcome Measure Information:
Title
Choroidal thickness
Description
Choroidal thickness measured by the optical coherence tomography
Time Frame
Within 4 hours
Secondary Outcome Measure Information:
Title
Retinal vessel density
Description
Superficial retinal vessel density measured by OCTA
Time Frame
Within 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Refractive error should be at least -6 Diopters or lower (spherical equivalent)
Best corrected visual acuity of at least 6/6
Non-smoker
Exclusion Criteria:
- Diagnosed with any ocular diseases and systemic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwok Cheung Andrew Lam, PhD
Organizational Affiliation
The Hong Kong Polytechinc University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of optometry
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Caffeine on Ocular Circulation in High Myopes
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