Early Detection and Prevention of Amblyopia and Visual Impairment Through Systematic Pediatric Vision Screening

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard screening procedure for amblyopia: 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.

New amblyopia screening method using a virtual reality headset.: 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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Sensitivity of a new amblyopia screening method compared to standard screening — At enrollment.
  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)

Trial sites (1)

More University Hospital, Strasbourg, France trials in France

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