Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort
MARETINE
1 other identifier
observational
29
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 6, 2019
CompletedStudy Start
First participant enrolled
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2019
CompletedMay 7, 2019
May 1, 2019
1 month
March 4, 2019
May 6, 2019
Conditions
Keywords
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
Interventions
Non mydriatic color retinography within 1 month before and within 1 hour after the marathon
Optical Coherence Tomography - Angiography within 1 month before and within 1 hour after the marathon
Blood pressure measurement within 1 month before and within 1 hour after the marathon
Eligibility Criteria
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
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.
PMID: 33824079DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martine MAUGET FAYSSE
Fondation A. de Rothschild
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