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

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ClinicalTrials.gov Identifier: NCT03958110
Recruitment Status : Not yet recruiting
First Posted : May 21, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.


Condition or disease Intervention/treatment
Rugby Professionals Concussion Diagnostic Test: OCT A

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber


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


Primary Outcome Measures :
  1. Average thickness difference of the RNFL on each eye in micrometers measured by OCT, between the beginning and the end of the season [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only Professional rugby Players
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Professional rugby players
Criteria

Inclusion Criteria:

  • Professional rugby player

Exclusion Criteria:

  • impossibility to realise OCT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958110


Contacts
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Contact: Mauget faysse Martine, MD +33148036437 mmfaysse@for.paris
Contact: Yavchitz Amélie, MD PhD +33148036454 ayavchitz@for.paris

Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019
Fondation Opthalmologique A de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03958110     History of Changes
Other Study ID Numbers: MMT_2019_3
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Retinophotography
OCT
Optical nerve