Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort

Sport Injury Clinical Trial

— MARETINE  

Official title:

Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864380
• Other study ID #: MMT_2018_10
• Status: Completed
• Start date: March 15, 2019
• Est. completion date: May 6, 2019

Study information

• Verified date: May 2019
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 6, 2019
• Est. primary completion date: April 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Person registered at the 2019 Paris Marathon

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Athletic Injuries
• Neovascularization, Pathologic
• Retinal Vascular Disorder
• Sport Injury
• Vascular Diseases

Intervention

Diagnostic Test:
• Color retinography
Non mydriatic color retinography within 1 month before and within 1 hour after the marathon
• OCT-A
Optical Coherence Tomography - Angiography within 1 month before and within 1 hour after the marathon
• Blood pressure measurement
Blood pressure measurement within 1 month before and within 1 hour after the marathon

Locations

Country	Name	City	State
France	Fondation A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Density of retinal vascular plexuses	Percentage, Measurement with OCT-A	up to 1 hour