Influence of Daily Activities on Retinal Microcirculation
The Influence of Daily Activities on Retinal Microcirculation in Normal Adults
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200040
- Shanghai Eye Disease Prevention & Treatment Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Healthy adults
- The age range was from 18 to 35 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
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Beverage consumption
Drink 300ml red wine (alcohol concentration:12.5%),
300ml coffee (caffeine concentration 72 mg), 300 ml Baijiu (Chinese liquor, alcohol concentration:12.5%)
, SipSparkTM Probiotics (facilitates ethanol degradation) was taken 0.5 hour prior to Baijiu consumption, 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
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
Sponsor
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- YFZX2017001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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