Effect of Caffeine on Ocular Circulation in High Myopes

NCT03294967 | Completed DMC

• 1 other identifier: HSEARS20170613002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

High Myopia; Choroid

Keywords

High Myopia; Caffeine; Choroidal Thickness; Choroidal Volume; Optical Coherence Tomography; Optical Coherence Tomography Angiography

Outcome Measures

Primary Outcomes (1)

• Choroidal thickness

  Choroidal thickness measured by the optical coherence tomography

  Within 4 hours

Secondary Outcomes (1)

• Retinal vessel density

  Within 4 hours

Study Arms (2)

Caffeine

ACTIVE COMPARATOR

To determine the effect of caffeine on ocular circulation in high myopes by consuming 200 mg caffeine capsule

Dietary Supplement: Caffeine

Vitamin E

PLACEBO COMPARATOR

To determine the effect of caffeine on ocular circulation in high myopes by consuming and 200 International Unit vitamin E control capsule, as control

Dietary Supplement: Vitamin E

Interventions

Caffeine DIETARY_SUPPLEMENT

As in group descriptions

Caffeine

Vitamin E DIETARY_SUPPLEMENT

As in group descriptions

Vitamin E

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Refractive error should be at least -6 Diopters or lower (spherical equivalent)
• Best corrected visual acuity of at least 6/6
• Non-smoker

You may not qualify if:

• \- Diagnosed with any ocular diseases and systemic diseases

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of optometry

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Caffeine; Vitamin E

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Officials

• Kwok Cheung Andrew Lam, PhD

  The Hong Kong Polytechinc University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not see the label of the capsule.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 27, 2017
• Study Start: September 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)