An observational study in Amblyopia, sponsored by University Hospital, Strasbourg, France. Not yet recruiting at 1 site in France. Open to participants aged 3 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by University Hospital, Strasbourg, France · Observational
Amblyopia, characterized by reduced visual acuity, develops in childhood due to insufficient sensory stimulation of the affected eye. It is the leading cause of low vision and loss of stereoscopic vision in both children and adults. Currently, 99 million people worldwide are affected, with recent projections indicating 222 million by 2040. Amblyopia can result from anisometropia (70%), strabismus (30%), or the presence of an ocular pathology (1%). Early management of these conditions (before the age of 7) can prevent the onset of amblyopia. Therefore, screening for these conditions is a major public health challenge to reduce the prevalence and associated costs of visual impairment.
The French-speaking Association of Strabology and Pediatric Ophthalmology (AFSOP) recommends systematic amblyopia screening for 3-year-old children. This screening involves measuring monocular visual acuity in both eyes (LEA chart at 3 meters), checking for strabismus (cover/uncover test), and performing a stereoscopic vision test (e.g., Lang I test).
Amblyopia is currently underdiagnosed for two main reasons: 1) it is often asymptomatic (75% of cases) and therefore cannot be detected without systematic screening; and 2) there is significant difficulty in accessing medical care in certain regions, and thus access to professionals capable of performing this screening (doctors, orthoptists). The difficulty in accessing healthcare professionals capable of screening for amblyopia in children aged 3 to 7 has already been raised.
We believe it would be beneficial to have an alternative screening method that is equivalent to the AFSOP-recommended method and accessible in areas with limited healthcare professionals. An eye-tracking system implemented in a virtual reality (VR) headset has recently been developed for monitoring eye movements. This system has shown effectiveness in rehabilitating visual field impairments in patients with traumatic brain injury. The system allows for remote monitoring of rehabilitation sessions, and data can be downloaded and viewed remotely via Wi-Fi.
The main objective of this study will be to estimate the sensitivity of the new VR-based eye-tracking screening method amblyopia screening method using an eye-tracking system implemented in a virtual reality headset compared to standard screening in children aged 3 to 7 years.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 40 is below the median of 156 across 39 observational studies indexed under Amblyopia.
Browse Amblyopia studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 3 to 7 years, including both amblyopic and non-amblyopic patients. All participants are recruited from the Ophthalmology Department of Strasbourg University Hospital (CHU Strasbourg) or referred by their ophthalmologists.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient aged between 3 and 7 years, with amblyopia diagnosed by standard reference screening within the three months preceding the signing of the informed consent form.
Diagnostic Test: Standard screening procedure for amblyopia · Diagnostic Test: New amblyopia screening method using a virtual reality headset.
Patient aged between 3 and 7 years, non-amblyopic, who underwent routine screening confirming the absence of amblyopia or any other ocular condition that could lead to amblyopia, within the three months prior to signing the informed consent form.
Diagnostic Test: Standard screening procedure for amblyopia · Diagnostic Test: New amblyopia screening method using a virtual reality headset.
The standard examination for amblyopia screening consists of three steps: A monocular visual acuity assessment using optotypes from the LEA scale, presented from the simplest to the most complex in front of each eye via an alternating occlusion mask. A cover/uncover test, during which the child is required to fixate on an image A Lang I stereopsis test performed under binocular vision.
The examination with the virtual reality headset consists of three main steps: A monocular visual acuity assessment using optotypes from the LEA scale, presented from the simplest to the most complex in front of each eye via an alternating occlusion mask. The eye-tracking system analyzes fixation and the visual response of the stimulated eye. A cover/uncover test, during which the child is required to fixate on an image projected inside the headset. Eye movements are tracked to detect any deviations or abnormalities in ocular coordination. A Lang I stereopsis test performed under binocular vision, in which the child must identify three-dimensional images hidden within a virtual board. The eye-tracking system detects fixation on the images and allows evaluation of depth perception
Sensitivity of a new amblyopia screening method compared to standard screening
Sensitivity of a new amblyopia screening method using an eye-tracking system implemented in a virtual reality headset, compared to standard screening, in children aged 3 to 7 years. Sensitivity = (true positives) / (false negatives + true positives)
Time frame: At enrollment.
Specificity of the eye-tracking system compared to standard screening
Specificity of the eye-tracking system implemented in a virtual reality headset, compared to standard screening in children aged 3 to 7 years. Specificity = (true negatives) / (false positives + true negatives)
Time frame: At enrollment.
Sensitivity and specificity of the eye-tracking system compared to the same tests performed during standard screening
These are respectively: Monocular visual acuity of both eyes measured using the LEA symbol scale at 3 meters, presented via the virtual reality interface. Presence or absence of a refixation movement during the cover/uncover test for strabismus screening. Presence or absence of stereoscopic vision anomalies evaluated by projecting a Lang I test under binocular vision within the virtual reality headset.
Time frame: At enrollment.
Cover/uncover test for strabismus screening : angle of deviation
The angle of deviation of movement of each eye (refixation movement) will be recorded using a cover/uncover test combined with monocular stimulation
Time frame: At enrollment.
Proportion of adverse events recorded during the diagnostic process
The proportion of adverse events will be recorded by the investigator accompanying the child during the examination with the virtual reality system across all study groups. In particular, adverse events related to the use of the virtual reality headset will be documented (nausea, discomfort, photophobia, seizure).
Time frame: Day of the diagnostic examination (Day 1)
Proportion of patients unable to complete the scheduled examination using the virtual reality headset
The proportion of patients unable to complete the scheduled examination using the virtual reality headset for any reason (including refusal to wear the headset, anxiety, or other factors) will be documented. This will include the number of patients for whom the examination could not be performed due to these reasons.
Time frame: Day of the diagnostic examination (Day 1)
Cover/uncover test for strabismus screening : direction
The direction of movement of each eye will be recorded using a cover/uncover test combined with monocular stimulation
Time frame: At enrollment
Cover/uncover test for strabismus screening : velocity
The velocity of movement of each eye (refixation movement) will be recorded using a cover/uncover test combined with monocular stimulation
Time frame: At enrollment
Plan to share: Undecided
Start is estimated for Sep 2025; primary completion for Sep 2026, 12 months later.
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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