ON RUGBY: Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Completed
CT.gov ID
NCT03958110
Collaborator
(none)
49
1
15.9
3.1
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
49 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
Actual Study Start Date
:
Jul 15, 2020
Actual Primary Completion Date
:
Oct 7, 2021
Actual Study Completion Date
:
Nov 10, 2021
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Professional rugby player
Exclusion Criteria:
- impossibility to realise OCT
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondation Opthalmologique A de Rothschild | Paris | France | 75019 |
Sponsors and Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT03958110
Other Study ID Numbers:
- MMT_2019_3
First Posted:
May 21, 2019
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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