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Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort (MARETINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864380
Recruitment Status : Completed
First Posted : March 6, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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Brief Summary:

The cardiovascular parameters of prolonged physical exercice have been studied, but very little data is available about the retinal vascularization.

The eye allows in vivo visualization of micro-vascularisation and is considered as an excellent marker of general vascular condition.

The marathon is an intense and prolonged exercise (running 42.195 km) in aerobic environment. Thus the investigators propose to study the vascular parameters of the retina, before and after this physical exercise.

This will allow : 1) to collect information on the physiology of the retinal vascularization to prolonged effort, 2) to detect any retinal damage (haemorrhages, edema, occlusion ...), not known to date.

The results may highlight vascular effects related to retinal hypoxia (venous tortuosity, haemorrhage, venous occlusion, hypoxic edema). Furthermore the results may urge prevention in this sport more and more democratized.

the investigators hypothesized that prolonged physical exercice causes a change in retinal vascularization.


Condition or disease Intervention/treatment
Retinal Vascular Disorder Sport Injury Diagnostic Test: Color retinography Diagnostic Test: OCT-A Diagnostic Test: Blood pressure measurement

Study Design
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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort
Actual Study Start Date : March 15, 2019
Actual Primary Completion Date : April 14, 2019
Actual Study Completion Date : May 6, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
Person running a marathon

Exams performed before (1 month maximum) and after the marathon (1 hour maximum) :

Color retinography Optical Coherence Tomography - Angiography (OCT-A) Blood pressure measurement

 Diagnostic Test: Color retinography
Non mydriatic color retinography within 1 month before and within 1 hour after the marathon

Diagnostic Test: OCT-A
Optical Coherence Tomography - Angiography within 1 month before and within 1 hour after the marathon

Diagnostic Test: Blood pressure measurement
Blood pressure measurement within 1 month before and within 1 hour after the marathon


Outcome Measures
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Primary Outcome Measures :
  1. Density of retinal vascular plexuses [ Time Frame: up to 1 hour ]
    Percentage, Measurement with OCT-A


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Person running a marathon
Criteria

Inclusion Criteria:

  • Person registered at the 2019 Paris Marathon

Exclusion Criteria:

  • Ophthalmological disorders making access to the fundus impossible for both eyes
Contacts and Locations
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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): NCT03864380


Locations
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France
Fondation A de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Martine MAUGET FAYSSE Fondation A. de Rothschild
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03864380    
Other Study ID Numbers: MMT_2018_10
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Fondation Ophtalmologique Adolphe de Rothschild:
Retinal Vascularization
Intense effort
OCT-A
Additional relevant MeSH terms:
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Vascular Diseases
Neovascularization, Pathologic
Athletic Injuries
Wounds and Injuries
 Metaplasia
Pathologic Processes
Cardiovascular Diseases