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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01115283
Other study ID # R01EY001728
Secondary ID R01EY001728
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date October 31, 2022

Study information

Verified date November 2022
Source University of California, Berkeley
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 31, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Perceptual learning
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 Games
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 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).

Locations

Country Name City State
United States Minor Hall 486, School of Optometry, University of California, Berkeley Berkeley California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Berkeley National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. Review. — View 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. — View 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. Epub 2006 Aug 22. — View 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 — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. eCollection 2016 Sep. — View 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. — View 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. eCollectio — View 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. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Amblyopic vision Improvement in amblyopic vision : visual acuity and stereoacuity 9 months
Secondary Spatial vision Improvement in spatial vision (eg. contrast sensitivity, positional acuity and spatial attention) 9 months
Secondary Temporal vision Improvement in temporal processing and temporal vision 9 months
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