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NCT03958110 Clinical Trial

Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

Concussion Clinical Trial

— ON RUGBY  

Official title:
Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03958110
Other study ID # MMT_2019_3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date November 10, 2021

Study information
Verified date November 2021
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main hypothesis is that exposure to repeated shocks is associated with a greater decrease in the thickness of optical nerve fibres. In order to show a association between the occurrence of concussions (in number and severity) and the variation in the thickness of the retinal nerve fibre layer, all participating rugby players will have an ophthalmologic examination (OCT and (retinophotography) at the beginning and end of the Rugby season.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date November 10, 2021
Est. primary completion date October 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Professional rugby player Exclusion Criteria: - impossibility to realise OCT

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• OCT A
OCT (Optical Coherence Tomography) and Retinophotography made at the beginning and end of the Rugby season.

Locations
Country Name City State
France Fondation Opthalmologique 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 Average thickness difference of the RNFL on each eye in micrometers measured by OCT, between the beginning and the end of the season 1 year
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