Amblyopia and Stereoptic Games for Vision

NCT05114252 | Unknown DMC FDA Device

• 1 other identifier: 2021-01172
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Amblyopia is the most common developmental vision disorder in children, caused by abnormal visual experience in early life, especially a difference in refraction between the eyes, a misalignment of the eye axes, a combination of both. Besides a significant reduced visual acuity, the patients show deficits in 3D vision and functional vision impairment like reduced reading speed, selective attention or motor control skills. The gold standard treatment for amblyopia, occlusion therapy, can lead to relapses or residual amblyopia (i.e., amblyopia that persist into adulthood). The current study aims to test the efficacy of a novel home-based child-friendly rehabilitation program for amblyopia, Vivid Vision Home, involving playing serious videogames on a virtual reality (VR) headset at home. The VR training will be compared to standard care (wearing a spectacle correction) and to age-matched typically developing individuals. A cross-over design will be used so that each participant will receive both treatments (games, spectacles). There is a growing number of studies showing benefits of binocular stimulation for visual acuity and stereovision, but provided mainly by level III studies, with a need for rigorous level I or II studies, using more engaging therapies, to confirm or refute the efficacy of this approach as an adjunct or replacement for current amblyopia treatments. Embedding binocular stimulation in engaging, immersive serious games delivered on VR headsets at home, as implemented by Vivid Vision Home, can address this question.

Conditions

Amblyopia; Healthy

Outcome Measures

Primary Outcomes (5)

• Best Corrected Visual Acuity

  Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.

  Baseline for Treatment A

• Best Corrected Visual Acuity

  Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.

  Post-test for Treatment A (2 months)

• Best Corrected Visual Acuity

  Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.

  Follow-up for Treatment A (2 months)/Baseline for Treatment B

• Best Corrected Visual Acuity

  Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.

  Post-test for Treatment B (2 months)

• Best Corrected Visual Acuity

  Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.

  Follow-up after Treatment B (2months)

Secondary Outcomes (26)

• Binocular vision measured in arc sec with clinical tests

  Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up

• Binocular vision measured in arc sec with a tablet test

  Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up

• Binocular vision (interocular misalignment) measured with clinical tests

  Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up

• Stereoacuity estimated with Vivid Vision Home software

  Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up

• Binocular vision estimated with Vivid Vision Home software

  Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up

Other Outcomes (2)

• Adherence

  Baseline, after experimental treatment (2 months)

• Adverse events

  Baseline, after experimental treatment (2 months)

Study Arms (3)

Participants with amblyopia in the serious games intervention

EXPERIMENTAL

Participants with amblyopia receiving the experimental intervention consisting of serious videogames focusing on binocular function (with image modification) in a virtual reality environment.

Device: Vivid Vision Home

Participants with amblyopia in the standard care intervention

ACTIVE COMPARATOR

Participants with amblyopia receiving the standard care intervention consisting of wearing spectacles with individualized refractive correction.

Behavioral: Refractive error correction

Healthy participants

ACTIVE COMPARATOR

Participants without amblyopia or other conditions receiving the experimental intervention consisting of serious videogames focusing on binocular function (without any image modification) in a virtual reality environment.

Device: Vivid Vision Home

Interventions

Vivid Vision Home DEVICE

The study intervention consists of playing serious games (Vivid Vision, San Francisco, USA) embedded in a virtual reality headset in a home environment 5 days a week for 30 minutes over 8 weeks (20 h of total gaming).

Healthy participants; Participants with amblyopia in the serious games intervention

Refractive error correction BEHAVIORAL

The control intervention will be refractive error correction that consists of wearing the lenses with the prescribed correction for 2 months.

Also known as: Standard care

Participants with amblyopia in the standard care intervention

Eligibility Criteria

• Age: 6 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged between 6 and 35 years old,
• Residual amblyopia defined as Best-Correct Visual Acuity (BCVA) of ≤ 20/20 in the amblyopic eye, an impairment of ≥ 2 lines in the amblyopic eye persisting even after refraction correction,
• Stable BCVA for at least 2 consecutive measurements over 6 months,
• Signed Informed Consent from the child's legal representative, by both the child and his/her legal representative for participants older than 14 years, or by full-aged participants themselves.

You may not qualify if:

• Untreated or newly diagnosed anisometropic, strabismic or combined amblyopia, that is a child with BCVA interocular difference of ≥ 2 lines,
• Current atropine treatment or atropine treatment 3 months prior to enrolment in the study,
• Auditory deficits or loss,
• Eye surgery except those to correct strabismus,
• Strabismus over 20 dioptres (D) or with large eccentric fixation,
• Coexistence of ocular or neurological disease (e.g., seizure or epilepsy, incomitant strabismus, nerve palsy, horror fusionis),
• Developmental delay or disorder (e.g., dyslexia, dyspraxia, attention deficity hyperactivity disorder, autism spectrum disorders),
• Inability to follow and complete the procedures of the study (e.g., psychological or sensorimotor disorders).
• HEALTHY INDIVIDUALS COHORT
• Aged between 6 and 35 years old,
• Signed Informed Consent from the child's legal representative, by both the child and his/her legal representative for participants older than 14 years, or by full-aged participants themselves.
• Auditory deficits or loss,
• Eye surgery except those to correct strabismus,
• Strabismus over 20D or with large eccentric fixation,
• Coexistence of ocular or neurological disease (e.g., seizure or epilepsy, incomitant strabismus, nerve palsy, horror fusionis),

Sponsors & Collaborators

• Pawel Matusz, PhD: lead
• University Hospital, Geneva: collaborator
• University of Lausanne Hospitals: collaborator
• Eye Hospital Jules Gonin: collaborator

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Related Publications (7)

• Vedamurthy I, Nahum M, Huang SJ, Zheng F, Bayliss J, Bavelier D, Levi DM. A dichoptic custom-made action video game as a treatment for adult amblyopia. Vision Res. 2015 Sep;114:173-87. doi: 10.1016/j.visres.2015.04.008. Epub 2015 Apr 24.

  PMID: 25917239 BACKGROUND

• Birch EE, Li SL, Jost RM, Morale SE, De La Cruz A, Stager D Jr, Dao L, Stager DR Sr. Binocular iPad treatment for amblyopia in preschool children. J AAPOS. 2015 Feb;19(1):6-11. doi: 10.1016/j.jaapos.2014.09.009.

  PMID: 25727578 BACKGROUND

• Gambacorta C, Nahum M, Vedamurthy I, Bayliss J, Jordan J, Bavelier D, Levi DM. An action video game for the treatment of amblyopia in children: A feasibility study. Vision Res. 2018 Jul;148:1-14. doi: 10.1016/j.visres.2018.04.005. Epub 2018 May 12.

  PMID: 29709618 BACKGROUND

• Ziak P, Holm A, Halicka J, Mojzis P, Pinero DP. Amblyopia treatment of adults with dichoptic training using the virtual reality oculus rift head mounted display: preliminary results. BMC Ophthalmol. 2017 Jun 28;17(1):105. doi: 10.1186/s12886-017-0501-8.

  PMID: 28659140 BACKGROUND

• Verghese P, McKee SP, Levi DM. Attention deficits in Amblyopia. Curr Opin Psychol. 2019 Oct;29:199-204. doi: 10.1016/j.copsyc.2019.03.011. Epub 2019 Mar 22.

  PMID: 31030000 BACKGROUND

• Grant S, Suttle C, Melmoth DR, Conway ML, Sloper JJ. Age- and stereovision-dependent eye-hand coordination deficits in children with amblyopia and abnormal binocularity. Invest Ophthalmol Vis Sci. 2014 Aug 5;55(9):5687-57015. doi: 10.1167/iovs.14-14745.

  PMID: 25097239 BACKGROUND

• Simon-Martinez C, Antoniou MP, Bouthour W, Bavelier D, Levi D, Backus BT, Dornbos B, Blaha JJ, Kropp M, Muller H, Murray M, Thumann G, Steffen H, Matusz PJ. Stereoptic serious games as a visual rehabilitation tool for individuals with a residual amblyopia (AMBER trial): a protocol for a crossover randomized controlled trial. BMC Ophthalmol. 2023 May 17;23(1):220. doi: 10.1186/s12886-023-02944-y.

  PMID: 37198558 DERIVED

MeSH Terms

Conditions

Amblyopia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Heimo Steffen, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The optometrists evaluating visual function will be blinded to the current treatment and the treatment order
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Monocentric blinded crossover randomised controlled trial

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 9, 2021
• Study Start: December 6, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The study protocol and statistical analysis plan will become available after approval of the protocol by the Commission Cantonale d'Ethique de la Recherche sur l'être humain (CCER) ethics board, as a study protocol peer-reviewed article. The data and code will become available upon publication of study results.
• Access Criteria: All interested parties will have access to pseudonymized data.

Locations

CH (1)