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OpenTrials
Completed

NCT Number: NCT03294967

Effect of Caffeine on Ocular Circulation in High Myopes

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.

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Key information

Conditions

Age range

20 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of optometry

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Dietary Supplement

As in group descriptions

Vitamin E

Dietary Supplement

As in group descriptions

Primary outcomes

  1. Choroidal thickness

    Time frame: Within 4 hours

    Choroidal thickness measured by the optical coherence tomography

Secondary outcomes

  1. Retinal vessel density

    Time frame: Within 4 hours

    Superficial retinal vessel density measured by OCTA

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2017
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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