NCT03864380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

March 4, 2019

Last Update Submit

May 6, 2019

Conditions

Keywords

Retinal VascularizationIntense effortOCT-A

Outcome Measures

Primary Outcomes (1)

  • Density of retinal vascular plexuses

    Percentage, Measurement with OCT-A

    up to 1 hour

Study Arms (1)

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 retinographyDiagnostic Test: OCT-ADiagnostic Test: Blood pressure measurement

Interventions

Color retinographyDIAGNOSTIC_TEST

Non mydriatic color retinography within 1 month before and within 1 hour after the marathon

Person running a marathon
OCT-ADIAGNOSTIC_TEST

Optical Coherence Tomography - Angiography within 1 month before and within 1 hour after the marathon

Person running a marathon

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

Person running a marathon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Person running a marathon

You may qualify if:

  • Person registered at the 2019 Paris Marathon

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation A de Rothschild

Paris, 75019, France

Location

Related Publications (1)

  • Mauget-Faysse M, Arej N, Paternoster M, Zuber K, Derrien S, Thevenin S, Alonso AS, Salviat F, Lafolie J, Vasseur V. Retinal and choroidal blood flow variations after an endurance exercise: A real-life pilot study at the Paris Marathon. J Sci Med Sport. 2021 Nov;24(11):1100-1104. doi: 10.1016/j.jsams.2021.03.013. Epub 2021 Mar 30.

MeSH Terms

Interventions

Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical Examination

Study Officials

  • Martine MAUGET FAYSSE

    Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 6, 2019

Study Start

March 15, 2019

Primary Completion

April 14, 2019

Study Completion

May 6, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations