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出境医 / 临床实验 / Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players (ON RUGBY)
Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players (ON RUGBY)
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 |
|---|---|
| Rugby Professionals Concussion | Diagnostic Test: OCT A |
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 : | July 15, 2020 |
| Estimated Primary Completion Date : | October 2021 |
| Estimated Study Completion Date : | October 2021 |
Arms and Interventions
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 [ Time Frame: 1 year ]
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 20, 2019 | ||||
| First Posted Date | May 21, 2019 | ||||
| Last Update Posted Date | September 14, 2020 | ||||
| Actual Study Start Date | July 15, 2020 | ||||
| Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
| Current 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 [ Time Frame: 1 year ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players | ||||
| Official Title | Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Professional rugby players | ||||
| Condition |
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| Intervention | Diagnostic Test: OCT A
OCT (Optical Coherence Tomography) and Retinophotography made at the beginning and end of the Rugby season.
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Actual Enrollment |
49 | ||||
| Original Estimated Enrollment |
50 | ||||
| Estimated Study Completion Date | October 2021 | ||||
| Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03958110 | ||||
| Other Study ID Numbers | MMT_2019_3 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Fondation Ophtalmologique Adolphe de Rothschild | ||||
| Study Sponsor | Fondation Ophtalmologique Adolphe de Rothschild | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Fondation Ophtalmologique Adolphe de Rothschild | ||||
| Verification Date | September 2020 | ||||
