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

NCT07112560 | Not Yet Recruiting

• 1 other identifier: 9746
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amblyopia

Keywords

Amblyopia; Visual impairment; New method for amblyopia screening; Pediatric amblyopia screening; Eye Tracking system

Outcome Measures

Primary Outcomes (1)

• 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)

  At enrollment.

Secondary Outcomes (7)

• Specificity of the eye-tracking system compared to standard screening

  At enrollment.

• Sensitivity and specificity of the eye-tracking system compared to the same tests performed during standard screening

  At enrollment.

• Cover/uncover test for strabismus screening : angle of deviation

  At enrollment.

• Proportion of adverse events recorded during the diagnostic process

  Day of the diagnostic examination (Day 1)

• Proportion of patients unable to complete the scheduled examination using the virtual reality headset

  Day of the diagnostic examination (Day 1)

Study Arms (2)

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.

Diagnostic Test: Standard screening procedure for amblyopia; Diagnostic Test: New amblyopia screening method using a virtual reality headset.

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.

Diagnostic Test: Standard screening procedure for amblyopia; Diagnostic Test: New amblyopia screening method using a virtual reality headset.

Interventions

Standard screening procedure for amblyopia DIAGNOSTIC_TEST

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.

Amblyopic patient; Non Amblyopic patient

New amblyopia screening method using a virtual reality headset. DIAGNOSTIC_TEST

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

Amblyopic patient; Non Amblyopic patient

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients aged 3 to 7 years at the time of consent signing.
• 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.

You may not qualify if:

• Amblyopic children currently undergoing treatment or having previously received treatment for amblyopia (optical correction, strabismus surgery, occlusion therapy, orthoptic rehabilitation).
• 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.).

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Related Publications (6)

• 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.

  PMID: 39687429 BACKGROUND

• 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.

  PMID: 34354660 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 33388188 BACKGROUND

• 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.

  PMID: 37417105 BACKGROUND

• 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.

  PMID: 31704700 BACKGROUND

MeSH Terms

Conditions

Amblyopia; Vision Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Léa DORMEGNY

CONTACT

0613325143; lea.dormegny@chru-strasbourg.fr

Lauriana SOLECKI

CONTACT

0369550939; lauriana.solecki@chru-strasbourg.fr

Study Design

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

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (1)