Eye Movements Recording Using a Mobile : Comparison to Standard Video-oculography in Young Athletes

NCT05211752 | Completed

• 1 other identifier: e-VOG Young Athletes
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on smartphones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in young athletes.

Conditions

Healthy

Keywords

Young Athletes

Outcome Measures

Primary Outcomes (1)

• Oculomotor profiles concordance

  Analyze of the concordance of the profiles obtained between the e-VOG digital assessment and the standard video-oculography assessment. Evaluation criteria: For each assessment, patients will be classified according to the number of oculomotor abnormality observed (based on identified parameters assessments: latency / speed / gain / altered ocular pursuits / fixation disorders / presence of internuclear ophthalmoplegia), in accordance with the literature standards.

  Day 0

Secondary Outcomes (10)

• Latency during horizontal reflex saccades

  Day 0

• Latency during vertical reflex saccades

  Day 0

• Latency during horizontal voluntary saccades

  Day 0

• Velocity during horizontal reflex saccades

  Day 0

• Velocity during vertical reflex saccades

  Day 0

Study Arms (2)

Healthy young athletes (Eye-Tracker®T2 + e-VOG)

Subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment.

Other: eVOG (Mobile VideoOculoGraphy)

Healthy young athletes (e-VOG + Eye-Tracker®T2)

Subjects who first perform e-VOG digital assessment, followed by the standard video-oculography assessment.

Other: eVOG (Mobile VideoOculoGraphy)

Interventions

eVOG (Mobile VideoOculoGraphy) OTHER

* Eyes movements assessed with e-VOG (mobile application, that uses the face detection features of the front camera to detect and record eye movements). * Study duration is about 20 minutes, the day the subject performs his standard video-oculography examination in routine care (using Eye-Tracker®T2)

Healthy young athletes (Eye-Tracker®T2 + e-VOG); Healthy young athletes (e-VOG + Eye-Tracker®T2)

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young athletes for whom a standard video-oculography exam is prescribed by the AS Monaco Football medical team as part of a preventive and follow-up approach performed in routine care. Eye-tracking is a relevant and essential assessment for the detection and monitoring of neuro-cognitive alterations in young athletes which may result from macro-trauma (concussion) or repeated micro-trauma (head game) occurring during the season. Standard video-oculography exam is carried out at the Center Rainier III (Princess Grace Hospital), in accordance with usual practices. It is a non-invasive device for eye movements recording, allowing doctors to measure standard parameters related to eye movements (Class IIa medical device, CE marking, according to Annexe IX of the directive 93/42/CE).

You may qualify if:

• Young Athletes from AS Monaco Football Academy
• referred by AS Monaco Medical Team to perform a video-oculography (Eye-Tracking) examination as part of routine care.
• covered by a health insurance system
• volunteer, able to give free, informed and written consent.
• For minors: whose holder of parental authority has given their written consent to participate following the information given by investigator.

You may not qualify if:

• General anaesthesia within 3 months.
• Head trauma within 3 months
• Neurological, ophthalmological or general pathology preventing the realization of a video-oculography examination.
• Oculomotor abnormality detectable on clinical examination by the neurologist prescribing the standard video-oculography examination.

Sponsors & Collaborators

• Association de Recherche Bibliographique pour les Neurosciences: lead
• Centre Hospitalier Princesse Grace: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Association Sportive Monaco Football Club: collaborator

Study Sites (1)

Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

Monaco, 98000, Monaco

Location

Study Officials

• Mikael COHEN, MD

  Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France

  PRINCIPAL INVESTIGATOR

• Sandrine LOUCHART de la CHAPELLE, MD-PHD

  Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco

  PRINCIPAL INVESTIGATOR

• Alain PESCE, PUPH

  Association de Recherche Bibliographique pour les Neurosciences

  STUDY DIRECTOR

• Sylvain BLANCHARD, MD-PHD

  Association Sportive Monaco Football Club

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: January 18, 2022
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)