AmblyopiaNCT01115283
An Active Approach to Treat Amblyopia: Perceptual Learning and Video Games
A study testing Perceptual learning, Video Games and Occlusion therapy in people with Amblyopia, run by University of California, Berkeley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- Perceptual learning, Video Games and Occlusion therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- adults and children (>5 years old) with normal vision or amblyopia
- amblyopia: interocular VA difference of at least 0.1 logMAR
Who cannot join
- any ocular pathological conditions, nystagmus
Trial locations and contacts
1 site in 1 country.
United States1 site
Minor Hall 486, School of Optometry, University of California, Berkeley
Berkeley, California, 94720
About this study
Official title: 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.
Read the 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.
- Conditions
- Amblyopia
- Being tested
- Perceptual learning, Video Games, Occlusion therapy
- Keywords
- amblyopia treatment, neural plasticity, perceptual learning, vision therapy, spatial vision, video games, occlusion therapy
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptual learningBehavioural
Also called vision therapy, vision training
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).
Video GamesBehavioural
Also called vision therapy, vision training
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).
Occlusion therapyBehavioural
Also called vision training,, vision therapy
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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). Receives: Behavioral: Video Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amblyopic vision
Improvement in amblyopic vision : visual acuity and stereoacuity
Measured: 9 months
Secondary outcomes (2)
Spatial vision
Improvement in spatial vision (eg. contrast sensitivity, positional acuity and spatial attention)
Measured: 9 months
Temporal vision
Improvement in temporal processing and temporal vision
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJul 2015
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Roger W Li, OD, PhD, Principal investigator, School of Optometry, Univeristy of california-BerkeleyDennis M Levi, OD, PhD, Principal investigator, School of Optometry, Univerisity of California-Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115283
- Sponsor's protocol ID
- R01EY001728
- Other IDs
- R01EY001728
- Status last verified
- Nov 2022
- First submitted
- 3 May 2010
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19008199Levi 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.
PubMed 19250947Bavelier 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.
PubMed 21068299Chung 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.
PubMed 25668775Li 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.
PubMed 27703690Li 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.
PubMed 19109504Li 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.
PubMed 17962456Li 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.
PubMed 16123415Li 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.
PubMed 15330715Chung 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.
PubMed 16930666Chung 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.
PubMed 18824189Li 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.
PubMed 25715870Chung 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.
PubMed 22558234Li 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.
PubMed 21912514Li 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.
PubMed 26909178
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Spatial and Temporal Vision in Adult and Juvenile Amblyopia
- ClinicalTrials.gov ID
- NCT01115283
- Acronym / sponsor ID
- R01EY001728
- Conditions
- Amblyopia
- Keywords
- amblyopia treatment, neural plasticity, perceptual learning, vision therapy, spatial vision, video games, occlusion therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jul 2015
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perceptual learning | Experimental | Behavioral: Perceptual learningPatients 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). |
| Occlusion therapy | Experimental | Behavioral: Occlusion therapyThe 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. |
| Video game | Experimental | Behavioral: Video GamesPatients 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). |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- adults and children (>5 years old) with normal vision or amblyopia
- amblyopia: interocular VA difference of at least 0.1 logMAR
Key exclusion criteria (1 listed)
- any ocular pathological conditions, nystagmus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perceptual learningAlso: vision therapy, vision trainingResearch 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). | Behavioural | Perceptual learning |
| Video GamesAlso: vision therapy, vision trainingResearch 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). | Behavioural | Video game |
| Occlusion therapyAlso: vision training,, vision therapyResearch 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). | Behavioural | Occlusion therapy |
Primary outcome
Amblyopic vision
Time frame: 9 months
Improvement in amblyopic vision : visual acuity and stereoacuity
2 secondary outcomes
Spatial vision
Time frame: 9 months
Temporal vision
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 19008199Levi 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.
- Background: PubMed 19250947Levi 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.
- Background: PubMed 21068299Bavelier 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.
- Background: PubMed 25668775Chung 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.
- Background: PubMed 27703690Li 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 publication: PubMed 19109504Li 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 publication: PubMed 17962456Li 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 publication: PubMed 16123415Li 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 publication: PubMed 15330715Li 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 publication: PubMed 16930666Chung 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 publication: PubMed 18824189Chung 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 publication: PubMed 25715870Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger W Li, OD, PhD principal investigator
School of Optometry, Univeristy of california-Berkeley
Dennis M Levi, OD, PhD principal investigator
School of Optometry, Univerisity of California-Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceptual learning, Video Games and Occlusion therapy in people with Amblyopia, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amblyopic vision (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01115283, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.