NCT01115283

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

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
5.2 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

7.3 years

First QC Date

May 3, 2010

Last Update Submit

November 10, 2022

Conditions

Amblyopia

Keywords

amblyopia treatmentneural plasticityperceptual learningvision therapyspatial visionvideo gamesocclusion therapy

Outcome Measures

Primary Outcomes (1)

  • Amblyopic vision

    Improvement in amblyopic vision : visual acuity and stereoacuity

    9 months

Secondary Outcomes (2)

  • Spatial vision

    9 months

  • Temporal vision

    9 months

Study Arms (3)

Perceptual learning

EXPERIMENTAL

Patients will be asked to practice a range of visual discrimination tasks for a period of time (each therapy session:1-2 hrs, 4-5 sessions/wk for \~1-6 months).

Behavioral: Perceptual learning

Occlusion therapy

EXPERIMENTAL

The fellow sound will be covered with a standard eye patch for a period of time (1-2 hrs/day, 4-5 days/wk for \~1-3 months). The idea is to push the brain to use the weaker amblyopic eye.

Behavioral: Occlusion therapy

Video game

EXPERIMENTAL

Patients will be asked to play videogames for a period of time (each therapy session:1-2 hrs, 4-5 sessions/wk for \~1-6 months).

Behavioral: Video Games

Interventions

Perceptual learningBEHAVIORAL

Research participants will be asked to practice a visual discrimination task (e.g. position acuity, contrast sensitivity, stereoacuity etc) in our laboratory for a period of time (2 hrs/day, 5 days/week).

Also known as: vision therapy, vision training
Perceptual learning
Video GamesBEHAVIORAL

Research participants will be asked to play "off-the-shelf" video games in our laboratory for a period of time (2 hrs/day, 5 days/week).

Also known as: vision therapy, vision training
Video game
Occlusion therapyBEHAVIORAL

Research participants will be required to cover the good eye during the day in order to push the brain to use the amblyopic eye (2 hrs/day, 5 days/week for 2-4 weeks).

Also known as: vision training,, vision therapy
Occlusion therapy

Eligibility Criteria

Age5 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adults and children (\>5 years old) with normal vision or amblyopia
  • amblyopia: interocular VA difference of at least 0.1 logMAR

You may not qualify if:

  • any ocular pathological conditions, nystagmus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minor Hall 486, School of Optometry, University of California, Berkeley

Berkeley, California, 94720, United States

Location

Related Publications (19)

  • Levi DM, Li RW. Improving the performance of the amblyopic visual system. Philos Trans R Soc Lond B Biol Sci. 2009 Feb 12;364(1515):399-407. doi: 10.1098/rstb.2008.0203.

    PMID: 19008199BACKGROUND

  • Levi DM, Li RW. Perceptual learning as a potential treatment for amblyopia: a mini-review. Vision Res. 2009 Oct;49(21):2535-49. doi: 10.1016/j.visres.2009.02.010. Epub 2009 Feb 27.

    PMID: 19250947BACKGROUND

  • Bavelier D, Levi DM, Li RW, Dan Y, Hensch TK. Removing brakes on adult brain plasticity: from molecular to behavioral interventions. J Neurosci. 2010 Nov 10;30(45):14964-71. doi: 10.1523/JNEUROSCI.4812-10.2010.

    PMID: 21068299BACKGROUND

  • Chung ST, Kumar G, Li RW, Levi DM. Characteristics of fixational eye movements in amblyopia: Limitations on fixation stability and acuity? Vision Res. 2015 Sep;114:87-99. doi: 10.1016/j.visres.2015.01.016. Epub 2015 Feb 7.

    PMID: 25668775BACKGROUND

  • 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, 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: 19109504RESULT

  • 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: 17962456RESULT

  • 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: 16123415RESULT

  • 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: 15330715RESULT

  • Chung ST, Li RW, Levi DM. Identification of contrast-defined letters benefits from perceptual learning in adults with amblyopia. Vision Res. 2006 Oct;46(22):3853-61. doi: 10.1016/j.visres.2006.06.014. Epub 2006 Aug 22.

    PMID: 16930666RESULT

  • Chung ST, Li RW, Levi DM. Learning to identify near-threshold luminance-defined and contrast-defined letters in observers with amblyopia. Vision Res. 2008 Dec;48(27):2739-50. doi: 10.1016/j.visres.2008.09.009. Epub 2008 Oct 18.

    PMID: 18824189RESULT

  • 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: 25715870RESULT

  • Chung ST, Li RW, Levi DM. Learning to identify near-acuity letters, either with or without flankers, results in improved letter size and spacing limits in adults with amblyopia. PLoS One. 2012;7(4):e35829. doi: 10.1371/journal.pone.0035829. Epub 2012 Apr 30.

    PMID: 22558234RESULT

  • 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: 21912514RESULT

  • 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: 26909178RESULT

  • Chung STL, Li RW, Silver MA, Levi DM. Donepezil Does Not Enhance Perceptual Learning in Adults with Amblyopia: A Pilot Study. Front Neurosci. 2017 Aug 7;11:448. doi: 10.3389/fnins.2017.00448. eCollection 2017.

    PMID: 28824369RESULT

  • 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: 29779684RESULT

  • Levi DM, Li RW, Silver MA, Chung STL. Sequential perceptual learning of letter identification and "uncrowding" in normal peripheral vision: Effects of task, training order, and cholinergic enhancement. J Vis. 2020 Apr 9;20(4):24. doi: 10.1167/jov.20.4.24.

    PMID: 32347910RESULT

  • Godinez A, Martin-Gonzalez S, Ibarrondo O, Levi DM. Scaffolding depth cues and perceptual learning in VR to train stereovision: a proof of concept pilot study. Sci Rep. 2021 May 12;11(1):10129. doi: 10.1038/s41598-021-89064-z.

    PMID: 33980895DERIVED

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roger W Li, OD, PhD

    School of Optometry, Univeristy of california-Berkeley

    PRINCIPAL INVESTIGATOR

  • Dennis M Levi, OD, PhD

    School of Optometry, Univerisity of California-Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 4, 2010

Study Start

July 1, 2015

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

US(1)