NCT01223716

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 adults with amblyopia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2004

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

Study Start

First participant enrolled

December 1, 2004

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

5 years

First QC Date

October 18, 2010

Last Update Submit

May 14, 2016

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
Behavioral: Perceptual learning

Video Game

EXPERIMENTAL
Behavioral: Video Game

Occlusion Therapy

EXPERIMENTAL
Behavioral: Crossover (Occlusion therapy + Video Game)

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 GameBEHAVIORAL

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
Crossover (Occlusion therapy + Video Game)BEHAVIORAL

Phase 1. 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). Phase 2. 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 therapy, vision training
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 with amblyopia (Age \>15 years)
  • Amblyopia: interocular visual acuity difference of at least 0.1 logMAR
  • All forms of amblyopia: Strabismic, anisometropic, refractive, deprivative, meridional amblyopia

You may not qualify if:

  • Any ocular pathological conditions (eg macula abnormalities, glaucoma), 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 (13)

  • 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, 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

  • 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: 16930666BACKGROUND

  • 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, 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

  • 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

  • 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: 19008199RESULT

  • 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: 19250947RESULT

  • 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

  • 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

  • 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

  • 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

MeSH Terms

Conditions

Amblyopia

Interventions

Crossing Over, Genetic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Homologous RecombinationRecombination, GeneticGenetic Phenomena

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
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Specialist

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

December 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

US(1)