An interventional study of eye-tracker in Autism Spectrum Disorder, sponsored by University Hospital, Tours. Recruiting at 1 site in France. Open to participants aged 1 Day to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Other
The goal of this observational study is to identify behavioral and physiological markers of social alterations in Autism Spectrum Disorders compared to Typically Developping peers. This single-centre study plan to use eye tracking to evaluate social disorders in Autism Spectrum Disorders (ASD). The investigators will estimate oculometric and pupillometric indices as potential ASD biomarkers. The study will last 4 years and will be organized in two phases.
In a first phase (expected to last 12-16 months), after an experimental validation in typical adults, relevant oculometric and pupillometric indices will be identified in a typical population of children and in a clinically diagnosed population of ASD children.
In a second phase of the protocol (expected to last 32-36 months), biomarkers identified in the first phase will be tested on a larger population including other neurodevelopmental disorders.
Phase 1
All groups have these 2 criteria in common:
Free, informed and signed consent of both parents Enrolment in the social security system
The other criteria per group are as follows:
Group of adult subjects without ASD : Age between 18 and 50 years Group of children without ASD
Phase 2
Age between 0 and 12 years Conformity to the diagnostic criteria of TND
Exclusion Criteria:
Phase 1:
All groups have the 2 common exclusion criteria Known uncorrected visual pathologies Known personal neurological pathologies
And they have these criteria per group:
Age between 18 and 50 years
Other: eye-tracker
Age between 2 and 12 years
Other: eye-tracker
Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11
Other: eye-tracker
Age between 0 and 12 years
Other: eye-tracker
Conformity to the diagnostic criteria of NDD
Other: eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Oculometric measurements 1: Tracking time
Mean of tracking time (ms) during entire stimuli duration
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Oculometric measurements 2: Fixation time on the screen
Mean of fixation time on the screen (ms) during entire stimuli duration
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration
Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Oculometric measurements 4: Fixation time on the mouth area of face stimuli
Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Pupillometric measurements
Mean of pupil dilation variation(mm) in response to entire stimuli duration
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Discriminative power
AUROC (Area Under the Receiver Operating Characteristics, in percent) analysis of combined oculometric and pupillometric measurements. Scale score : 0-100% (above 70% : good performance; above 80% : excellent performance; above 90% : outstanding performance)
Time frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
Plan to share: No
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University Hospital, Tours