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Influence of Daily Activities on Retinal Microcirculation

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ClinicalTrials.gov Identifier: NCT03416088
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Jiannan Huang, Shanghai Eye Disease Prevention and Treatment Center

Brief Summary:
The daily behaviors such as drinking,coffee and reading may have influence on the function or morphology of the retinal microcirculation in healthy people.A recent study found that the fingertips microvascular bed constricted obviously after the intake of a cup of coffee with caffeine, it significantly reduced blood flow to the fingers; Long reading of electronic products can induce significant dry eye symptoms, affect visual quality, and cause asthenopia. Microcirculation is critical for regulating vascular resistance and blood flow in organs. Fundus blood vessels is the only visible microvascular in vivo, its morphology and function changes not only associated with eye disease, but also with cardiovascular and cerebrovascular diseases. Optical coherence tomography angiography (OCTA) is a new technique which could acquire blood flow information in a non-invasive way without the use of dye. The study tried to detect the influence of daily behaviors such as drinking, coffee and reading on the retinal microcirculation with OCTA, and provide reference for health behaviors.

Condition or disease Intervention/treatment Phase
Retinal Microcirculation Disorder Dietary Supplement: water deprivation,water,wine,coffee Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Sequential Assignment
Intervention Model Description: 50 participants will be enrolled. Each subject undergoes three period which include water deprivation,drinking pure water,and drinking coffee or wine.Each period lasts 1.5 hours.OCTA images are taken every 30 minutes.OCTA examination are taken 16 times in total.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Influence of Daily Activities on Retinal Microcirculation in Normal Adults
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Liquid volume
Drink 300ml wine (alcohol concentration:13%) or 300ml coffee (caffeine concentration 1.2%).
Dietary Supplement: water deprivation,water,wine,coffee
The participants drink 300ml wine (alcohol concentration:13%)or 300ml coffee (caffeine concentration 1.2%).




Primary Outcome Measures :
  1. Vessel diameter index (caliber) (VDI) [ Time Frame: 3 weeks ]
    VDI is calculated using both the vessel area map and the skeletonized vessel map, to yield the averaged vessel caliber.

  2. Vessel area density (VAD) [ Time Frame: 3 weeks ]
    VAD is calculated as a unit-less ratio of the total image area occupied by the vasculature to the total image area in the binary vessel maps.

  3. Flow impairment zone (FIZ) [ Time Frame: 3 weeks ]
    FIZ: calculated by summing all 'no-flow' pixels up.



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Ages Eligible for Study:   19 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Healthy adults
  2. The age range was from 18 to 25 years old
  3. Without another eye disease besides ametropia
  4. The spherical equivalent is equal or above minus 3.00 diopters
  5. No smoking or drinking
  6. No diabetes, hypertension, heart disease, liver or kidney dysfunction
  7. No medication taken recently

Exclusion Criteria

  1. Mental disorders such as depression and anxiety
  2. Intellectual disabilities
  3. Female in menstruation, gestation period, perinatal period or lactation period
  4. Unable to cooperate with eye examinations and test procedures
  5. Heart disease, hypertension, diabetes, liver and kidney dysfunction and other chronic diseases
  6. Patients with fever, acute infectious diseases
  7. Other conditions that are not suitable for drinking alcohol or coffee, such as allergic to alcohol or coffee

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416088


Contacts
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Contact: Haidong Zou, Ph.D 13311986528 zouhaidong@263.net

Locations
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China, Shanghai
Shanghai Eye Disease Prevention & Treatment Center Recruiting
Shanghai, Shanghai, China, 200040
Contact: Haidong Zou, Ph.D    13311986528    zouhaidong@263.net   
Sponsors and Collaborators
Jiannan Huang

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Responsible Party: Jiannan Huang, Director, Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT03416088     History of Changes
Other Study ID Numbers: YFZX2017001
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data because of personal privacy.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiannan Huang, Shanghai Eye Disease Prevention and Treatment Center:
wine,coffee,reading,retinal microcirculation,optical coherence tomography angiography