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An Active Approach to Treat Amblyopia: Perceptual Learning and Video Games

Primary Purpose

Amblyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perceptual learning
Video Games
Occlusion therapy
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring amblyopia treatment, neural plasticity, perceptual learning, vision therapy, spatial vision, video games, occlusion therapy

Eligibility Criteria

5 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • any ocular pathological conditions, nystagmus

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Perceptual learning

Occlusion therapy

Video game

Arm Description

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).

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.

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).

Outcomes

Primary Outcome Measures

Amblyopic vision
Improvement in amblyopic vision : visual acuity and stereoacuity

Secondary Outcome Measures

Spatial vision
Improvement in spatial vision (eg. contrast sensitivity, positional acuity and spatial attention)
Temporal vision
Improvement in temporal processing and temporal vision

Full Information

First Posted
May 3, 2010
Last Updated
November 10, 2022
Sponsor
University of California, Berkeley
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT01115283
Brief Title
An Active Approach to Treat Amblyopia: Perceptual Learning and Video Games
Official Title
Improving Spatial and Temporal Vision in Adult and Juvenile Amblyopia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Our previous findings (see CITATIONS) show that the adult amblyopic brain is still plastic and malleable, suggesting that active approach is potential useful in treating amblyopia. The goal of this project is to assess the limits and mechanisms of neural plasticity in both normal and amblyopic spatial vision. This study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia. Research participants will be asked to practice a visual discrimination task (perceptual learning) or to play video games with the amblyopic eye for a period of time. A range of visual functions will be monitored during the course of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
amblyopia treatment, neural plasticity, perceptual learning, vision therapy, spatial vision, video games, occlusion therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perceptual learning
Arm Type
Experimental
Arm Description
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).
Arm Title
Occlusion therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Video game
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Perceptual learning
Other Intervention Name(s)
vision therapy, vision training
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Video Games
Other Intervention Name(s)
vision therapy, vision training
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Occlusion therapy
Other Intervention Name(s)
vision training,, vision therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Amblyopic vision
Description
Improvement in amblyopic vision : visual acuity and stereoacuity
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Spatial vision
Description
Improvement in spatial vision (eg. contrast sensitivity, positional acuity and spatial attention)
Time Frame
9 months
Title
Temporal vision
Description
Improvement in temporal processing and temporal vision
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adults and children (>5 years old) with normal vision or amblyopia amblyopia: interocular VA difference of at least 0.1 logMAR Exclusion Criteria: any ocular pathological conditions, nystagmus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger W Li, OD, PhD
Organizational Affiliation
School of Optometry, Univeristy of california-Berkeley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis M Levi, OD, PhD
Organizational Affiliation
School of Optometry, Univerisity of California-Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minor Hall 486, School of Optometry, University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19008199
Citation
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.
Results Reference
background
PubMed Identifier
19250947
Citation
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.
Results Reference
background
PubMed Identifier
21068299
Citation
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.
Results Reference
background
PubMed Identifier
25668775
Citation
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.
Results Reference
background
PubMed Identifier
27703690
Citation
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.
Results Reference
background
PubMed Identifier
19109504
Citation
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.
Results Reference
result
PubMed Identifier
17962456
Citation
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.
Results Reference
result
PubMed Identifier
16123415
Citation
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.
Results Reference
result
PubMed Identifier
15330715
Citation
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.
Results Reference
result
PubMed Identifier
16930666
Citation
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.
Results Reference
result
PubMed Identifier
18824189
Citation
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.
Results Reference
result
PubMed Identifier
25715870
Citation
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.
Results Reference
result
PubMed Identifier
22558234
Citation
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.
Results Reference
result
PubMed Identifier
21912514
Citation
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.
Results Reference
result
PubMed Identifier
26909178
Citation
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.
Results Reference
result
PubMed Identifier
28824369
Citation
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.
Results Reference
result
PubMed Identifier
29779684
Citation
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.
Results Reference
result
PubMed Identifier
32347910
Citation
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.
Results Reference
result
PubMed Identifier
33980895
Citation
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.
Results Reference
derived

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An Active Approach to Treat Amblyopia: Perceptual Learning and Video Games

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