- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01115283
An Active Approach to Treat Amblyopia: Perceptual Learning and Video Games
November 10, 2022 updated by: University of California, Berkeley
Improving Spatial and Temporal Vision in Adult and Juvenile Amblyopia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Berkeley, California, United States, 94720
- Minor Hall 486, School of Optometry, University of California, Berkeley
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perceptual learning
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).
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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).
Other Names:
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Experimental: Occlusion therapy
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.
|
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).
Other Names:
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Experimental: Video game
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).
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amblyopic vision
Time Frame: 9 months
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Improvement in amblyopic vision : visual acuity and stereoacuity
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9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spatial vision
Time Frame: 9 months
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Improvement in spatial vision (eg.
contrast sensitivity, positional acuity and spatial attention)
|
9 months
|
Temporal vision
Time Frame: 9 months
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Improvement in temporal processing and temporal vision
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9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
October 31, 2022
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
May 3, 2010
First Submitted That Met QC Criteria
May 3, 2010
First Posted (Estimate)
May 4, 2010
Study Record Updates
Last Update Posted (Actual)
November 14, 2022
Last Update Submitted That Met QC Criteria
November 10, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01EY001728 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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