Early Detection and Prevention of Amblyopia and Visual Impairment Through Systematic Pediatric Vision Screening
NCT ID: NCT07112560
Last Updated: 2025-08-08
Study Results
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Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-09-30
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Amblyopic patient
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.
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
Non Amblyopic patient
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients followed in the Ophthalmology Department of Strasbourg University Hospital (CHU Strasbourg).
* Holders of parental authority must be affiliated with or beneficiaries of the health insurance system.
* Holders of parental authority must be capable of understanding the objectives and risks related to the research, and able to provide dated and signed informed consent.
* Amblyopic patients must have amblyopia diagnosed by the reference screening method.
* Non-amblyopic patients must have undergone routine screening confirming the absence of amblyopia or any other ocular condition that could lead to amblyopia.
* Screening must be performed in the Ophthalmology Department of CHU Strasbourg, unless a prior screening has been performed according to established guidelines and fully documented in a report by the patient's ophthalmologist (detailed results of the three standard screening tests).
* The screening examination must have been performed within the three months prior to the signing of the informed consent form.
Exclusion Criteria
* Children presenting conditions or states that may cause side effects related to the use of the virtual reality headset (epilepsy, neurological or developmental disorders, autism spectrum disorders, dizziness, nausea, claustrophobia, etc.).
* Inability to provide informed information to the patient or holders of parental authority (emergency situations, difficulties in patient comprehension, etc.).
3 Years
7 Years
ALL
Yes
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Nouvel Hôpital Civil
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Misawa M, Bajin IY, Zhang B, Daibert-Nido M, Tchao D, Garcia-Giler E, Cheung K, Appel L, Nasir P, Reginald A, Tabori U, Bartels U, Ramaswamy V, Markowitz SN, Bouffet E, Reber M. A telerehabilitation program to improve visual perception in children and adolescents with hemianopia consecutive to a brain tumor: a single-arm feasibility and proof-of-concept trial. EClinicalMedicine. 2024 Nov 29;78:102955. doi: 10.1016/j.eclinm.2024.102955. eCollection 2024 Dec.
Daibert-Nido M, Pyatova Y, Cheung K, Nayomi C, Markowitz SN, Bouffet E, Reber M. Case Report: Visual Rehabilitation in Hemianopia Patients. Home-Based Visual Rehabilitation in Patients With Hemianopia Consecutive to Brain Tumor Treatment: Feasibility and Potential Effectiveness. Front Neurol. 2021 Jul 21;12:680211. doi: 10.3389/fneur.2021.680211. eCollection 2021.
Bois C, Milcent K, Dufourg M, Charles M. Bilan de santé des enfants de 3-4 ans en école maternelle par la Protection Maternelle Infantile en 2014-2016 : disparités départementales des pratiques. Bulletin Epidémiologique Hebdomadaire. Janvier 2020
Lequeux L, Thouvenin D, Couret C, Audren F, Costet C, Dureau P, Leruez S, Defoordt-Dhellemmes S, Daien V, Espinasse Berrod MA, Arsene S, Lebranchu P, Denis D, Bui-Quoc E, Speeg-Schatz C. [Vision screening for children: Recommended practices from AFSOP]. J Fr Ophtalmol. 2021 Feb;44(2):244-251. doi: 10.1016/j.jfo.2020.07.005. Epub 2020 Dec 30. French.
Kaur S, Sharda S, Aggarwal H, Dadeya S. Comprehensive review of amblyopia: Types and management. Indian J Ophthalmol. 2023 Jul;71(7):2677-2686. doi: 10.4103/IJO.IJO_338_23.
Fu Z, Hong H, Su Z, Lou B, Pan CW, Liu H. Global prevalence of amblyopia and disease burden projections through 2040: a systematic review and meta-analysis. Br J Ophthalmol. 2020 Aug;104(8):1164-1170. doi: 10.1136/bjophthalmol-2019-314759. Epub 2019 Nov 8.
Other Identifiers
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9746
Identifier Type: -
Identifier Source: org_study_id
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