CClinicalTrials.gg
CompletedNCT03958110ON RUGBYUpdated Nov 17, 2021

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

An observational study in Rugby Professionals and Concussion, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-17.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
49
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rugby Professionals
  • Concussion

Keywords

  • Retinophotography
  • OCT
  • Optical nerve
03

In context

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Professional rugby players

Inclusion criteria

  • Professional rugby player

Exclusion criteria

Exclusion Criteria:

  • impossibility to realise OCT
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
49 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testOCT A

    OCT (Optical Coherence Tomography) and Retinophotography made at the beginning and end of the Rugby season.

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Fondation Opthalmologique A de Rothschild
    Paris, 75019, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03958110
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
May 21, 2019
Start date
Jul 15, 2020
Primary completion
Oct 7, 2021
Completion
Nov 10, 2021
Last update
Nov 17, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion