NCT05522972

Brief Summary

Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Sep 2022Aug 2029

First Submitted

Initial submission to the registry

August 24, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

September 13, 2022

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

7 years

First QC Date

August 24, 2022

Last Update Submit

December 8, 2025

Conditions

Keywords

perceptual learningvideo gamesvisual plasticityamblyopia treatmentpathophysiology of amblyopiavision trainingstereoacuitystrabismus

Outcome Measures

Primary Outcomes (2)

  • Change in visual acuity before and after the intervention

    "Visual acuity", the gold standard for vision testing, will be measured. Participants will be asked to read letters on a LogMAR letter chart. The smallest letters that can be read correspond to visual acuity (e.g., Snellen acuity of 20/20, letter-stroke width = 1 minute of arc).

    9 months

  • Change in stereoacuity before and after the intervention

    "Stereoacuity" will be measured psychophysically using a new stereoacuity function test (1.25, 2.5, 5, 10, 15, \& 20 cycles per degree) developed in our previous studies (Li et al 2016). A custom-built 4-mirror haploscope will be used to present a stereogram to each eye. Stereoacuity is the smallest stereo disparity that can be seen in binocular vision (in the unit of seconds of arc, arcsec). The conventional stereoacuity tests (including Randot Stereoacuity Test, Stereofly Test \& Preschool Stereo Test) will also be used to measure stereoacuity. Participants will be asked to wear a pair of 3D glasses and to identify the target 3D pictures at various 3D levels. The smallest 3D disparities that can be seen correspond to stereoacuity (e.g. normal range of stereoacuity: 50 seconds of arc or better).

    9 months

Secondary Outcomes (2)

  • Change in contrast sensitivity before and after the intervention

    9 months

  • Change in positional (or Vernier) acuity before and after the intervention

    9 months

Study Arms (3)

Video Games

EXPERIMENTAL

Participants will be required to play video games for a period of time: 1-2 hrs per session, 4-5 sessions/week for \~1-6 months

Behavioral: Video Game Vision Training

Perceptual learning

EXPERIMENTAL

Participants will be required to practice a visual discrimination task (e.g. visual acuity, position acuity, contrast sensitivity, \& stereoacuity) for a period of time: 1-2 hrs per session, 4-5 sessions/week for \~1-6 months

Behavioral: Perceptual Learning

Occlusion therapy

ACTIVE COMPARATOR

Participants will be required to cover the dominant eye during the day in order to push the brain to use the fellow amblyopic eye: 1-2 hrs per session, 4-5 sessions/week for \~1-6 months

Behavioral: Occlusion Therapy

Interventions

A new approach for improving amblyopic vision using video games

Video Games

A new approach for improving amblyopic vision with perceptual learning

Perceptual learning

Conventional treatment for amblyopia

Occlusion therapy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adults and children with normal vision or amblyopia
  • amblyopia: interocular VA difference of 0.1 logMAR or more

You may not qualify if:

  • any ocular pathological conditions, nystagmus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University College of Optometry

Fort Lauderdale, Florida, 33328, United States

RECRUITING

Related Publications (12)

  • Li RW, Li BZ, Chat SW, Patel SS, Chung STL, Levi DM. Playing three-dimensional video games boosts stereo vision. Curr Biol. 2024 Jun 3;34(11):R524-R525. doi: 10.1016/j.cub.2024.04.032.

    PMID: 38834021BACKGROUND
  • Leung TW, Li RW, Kee CS. Brief Adaptation to Astigmatism Reduces Meridional Anisotropy in Contrast Sensitivity. Invest Ophthalmol Vis Sci. 2023 Sep 1;64(12):4. doi: 10.1167/iovs.64.12.4.

    PMID: 37656478BACKGROUND
  • Li RW, Levi DM. Characterizing the mechanisms of improvement for position discrimination in adult amblyopia. J Vis. 2004 Jun 1;4(6):476-87. doi: 10.1167/4.6.7.

    PMID: 15330715BACKGROUND
  • Li RW, Klein SA, Levi DM. Prolonged perceptual learning of positional acuity in adult amblyopia: perceptual template retuning dynamics. J Neurosci. 2008 Dec 24;28(52):14223-9. doi: 10.1523/JNEUROSCI.4271-08.2008.

    PMID: 19109504BACKGROUND
  • Li RW, Provost A, Levi DM. Extended perceptual learning results in substantial recovery of positional acuity and visual acuity in juvenile amblyopia. Invest Ophthalmol Vis Sci. 2007 Nov;48(11):5046-51. doi: 10.1167/iovs.07-0324.

    PMID: 17962456BACKGROUND
  • Li RW, Young KG, Hoenig P, Levi DM. Perceptual learning improves visual performance in juvenile amblyopia. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3161-8. doi: 10.1167/iovs.05-0286.

    PMID: 16123415BACKGROUND
  • Li RW, Ngo CV, Levi DM. Relieving the attentional blink in the amblyopic brain with video games. Sci Rep. 2015 Feb 26;5:8483. doi: 10.1038/srep08483.

    PMID: 25715870BACKGROUND
  • Li RW, Ngo C, Nguyen J, Levi DM. Video-game play induces plasticity in the visual system of adults with amblyopia. PLoS Biol. 2011 Aug;9(8):e1001135. doi: 10.1371/journal.pbio.1001135. Epub 2011 Aug 30.

    PMID: 21912514BACKGROUND
  • Li RW, Tran KD, Bui JK, Antonucci MM, Ngo CV, Levi DM. Improving Adult Amblyopic Vision with Stereoscopic 3-Dimensional Video Games. Ophthalmology. 2018 Oct;125(10):1660-1662. doi: 10.1016/j.ophtha.2018.04.025. Epub 2018 May 18. No abstract available.

    PMID: 29779684BACKGROUND
  • Li RW, Tran TT, Craven AP, Leung TW, Chat SW, Levi DM. Sharpening coarse-to-fine stereo vision by perceptual learning: asymmetric transfer across the spatial frequency spectrum. R Soc Open Sci. 2016 Jan 20;3(1):150523. doi: 10.1098/rsos.150523. eCollection 2016 Jan.

    PMID: 26909178BACKGROUND
  • Li RW, So K, Wu TH, Craven AP, Tran TT, Gustafson KM, Levi DM. Monocular blur alters the tuning characteristics of stereopsis for spatial frequency and size. R Soc Open Sci. 2016 Sep 21;3(9):160273. doi: 10.1098/rsos.160273. eCollection 2016 Sep.

    PMID: 27703690BACKGROUND
  • Li RW, Levi DM, Klein SA. Perceptual learning improves efficiency by re-tuning the decision 'template' for position discrimination. Nat Neurosci. 2004 Feb;7(2):178-83. doi: 10.1038/nn1183. Epub 2004 Jan 18.

    PMID: 14730311BACKGROUND

MeSH Terms

Conditions

AmblyopiaStrabismus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOcular Motility DisordersCranial Nerve Diseases

Study Officials

  • Roger W Li, OD, PhD

    Nova Southeastern University College of Optometry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger W Li, OD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 31, 2022

Study Start

September 13, 2022

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations