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

May 6, 2019 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

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

  • France
      • Paris, France, 75019
        • Fondation A de Rothschild

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Person running a marathon

Description

Inclusion Criteria:

  • Person registered at the 2019 Paris Marathon

Exclusion Criteria:

  • Ophthalmological disorders making access to the fundus impossible for both eyes

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Density of retinal vascular plexuses
Time Frame: up to 1 hour
Percentage, Measurement with OCT-A
up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

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

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)

March 15, 2019

Primary Completion (ACTUAL)

April 14, 2019

Study Completion (ACTUAL)

May 6, 2019

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (ACTUAL)

March 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMT_2018_10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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