- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03416088
Influence of Daily Activities on Retinal Microcirculation
February 21, 2022 updated by: Jiannan Huang
The Influence of Daily Activities on Retinal Microcirculation in Normal Adults
The daily behaviors such as drinking coffee, wine, reading, exercise and body postural changes 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.
Magnetic resonance imaging (MRI) can quantitatively evaluation of cerebral blood flow and retina-choroid blood flow using the noninvasive arterial spin labeling technique in a large field of view (FOV) without depth limitations.The study tried to detect the influence of daily behaviors such as drinking coffee, red wine, reading ,and exercise on the retinal microcirculation with OCTA and MRI, and provide reference for health behaviors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200040
- Shanghai Eye Disease Prevention & Treatment Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria
- Healthy adults
- The age range was from 18 to 25 years old
- Without another eye disease besides ametropia
- The spherical equivalent is equal or above minus 3.00 diopters
- No smoking or drinking
- Average daily caffeine consumption no more than 1 cup of coffee
- No diabetes, hypertension, heart disease, liver or kidney dysfunction
- No medication taken recently
Exclusion Criteria
- Mental disorders such as depression and anxiety
- Intellectual disabilities
- Female in menstruation, gestation period, perinatal period or lactation period
- Unable to cooperate with eye examinations and test procedures
- Heart disease, hypertension, diabetes, liver and kidney dysfunction and other chronic diseases
- Patients with fever, acute infectious diseases
- Other conditions that are not suitable for drinking alcohol or coffee, such as allergic to alcohol or coffee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Beverage consumption
Drink 300ml red wine (alcohol concentration:12.5%),
300ml coffee (caffeine concentration 72 mg), or 300ml water.
|
The participants drink 300ml wine (alcohol concentration:12.5%)or
300ml coffee (caffeine concentration 72 mg), or water.
|
EXPERIMENTAL: Daily reading
Reading paper books, playing video games with mobile phones, or non-reading.
|
Reading paper books, playing video games with mobile phones, or non-reading for 8 hours.
|
EXPERIMENTAL: Body motion
Exercise and body postural changes.
|
Exercise or body postural changes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vessel diameter index (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.
|
3 weeks
|
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 weeks
|
Flow impairment region (FIR)
Time Frame: 3 weeks
|
FIZ: calculated by summing all 'no-flow' pixels up.
|
3 weeks
|
Retina-choroid blood flow
Time Frame: 3 weeks
|
Blood flow for the entire retinal thickness were determined as a function of the distance from the optic nerve head, where the blood flow was measured at the peaks of the projection profiles.
An region of interest outlining the posterior retina with a size of 0.7 to 0.8 mm across the retina-choroid thickness in the parafoveal region was used to obtain the blood flow signal time courses and averaged the values.
|
3 weeks
|
Cerebral blood flow (CBF)
Time Frame: 3 weeks
|
The frontal lobe was selected as the region of interest (ROI) to measure and average the changes in CBF
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Malerba S, Turati F, Galeone C, Pelucchi C, Verga F, La Vecchia C, Tavani A. A meta-analysis of prospective studies of coffee consumption and mortality for all causes, cancers and cardiovascular diseases. Eur J Epidemiol. 2013 Jul;28(7):527-39. doi: 10.1007/s10654-013-9834-7. Epub 2013 Aug 11.
- Ronksley PE, Brien SE, Turner BJ, Mukamal KJ, Ghali WA. Association of alcohol consumption with selected cardiovascular disease outcomes: a systematic review and meta-analysis. BMJ. 2011 Feb 22;342:d671. doi: 10.1136/bmj.d671.
- Lawrenson JG, Hull CC, Downie LE. The effect of blue-light blocking spectacle lenses on visual performance, macular health and the sleep-wake cycle: a systematic review of the literature. Ophthalmic Physiol Opt. 2017 Nov;37(6):644-654. doi: 10.1111/opo.12406.
- Karti O, Zengin MO, Kerci SG, Ayhan Z, Kusbeci T. ACUTE EFFECT OF CAFFEINE ON MACULAR MICROCIRCULATION IN HEALTHY SUBJECTS: An Optical Coherence Tomography Angiography Study. Retina. 2019 May;39(5):964-971. doi: 10.1097/IAE.0000000000002058.
- Luksch A, Resch H, Weigert G, Sacu S, Schmetterer L, Garhofer G. Acute effects of intravenously administered ethanol on retinal vessel diameters and flicker induced vasodilatation in healthy volunteers. Microvasc Res. 2009 Sep;78(2):224-9. doi: 10.1016/j.mvr.2009.06.001. Epub 2009 Jun 10.
- Strang NM, Claus ED, Ramchandani VA, Graff-Guerrero A, Boileau I, Hendershot CS. Dose-dependent effects of intravenous alcohol administration on cerebral blood flow in young adults. Psychopharmacology (Berl). 2015 Feb;232(4):733-44. doi: 10.1007/s00213-014-3706-z. Epub 2014 Aug 12.
- Kojima S, Sugiyama T, Kojima M, Azuma I I, Ito S. Effect of the consumption of ethanol on the microcirculation of the human optic nerve head in the acute phase. Jpn J Ophthalmol. 2000 May;44(3):318-9. doi: 10.1016/s0021-5155(00)00158-1.
- Molnar F, Frank CC. Determining the causes of postural hypotension. Can Fam Physician. 2018 Jan;64(1):40. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2017
Primary Completion (ACTUAL)
October 31, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
January 17, 2018
First Submitted That Met QC Criteria
January 23, 2018
First Posted (ACTUAL)
January 30, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 9, 2022
Last Update Submitted That Met QC Criteria
February 21, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- YFZX2017001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share individual participant data because of personal privacy.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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