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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01223716
Other study ID # CPHS#2003-11-83
Secondary ID R01EY001728
Status Completed
Phase N/A
First received October 18, 2010
Last updated October 18, 2010
Start date December 2004
Est. completion date December 2009

Study information

Verified date May 2008
Source University of California, Berkeley
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
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 adults 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 amblyopic spatial vision. This study uses psychophysical measures to study neural plasticity in adults with amblyopia. Research participants will be asked 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 20
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 75 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Any ocular pathological conditions (eg macula abnormalities, glaucoma), nystagmus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


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 Game
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).
Crossover (Occlusion therapy + Video Game)
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).

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 (8)

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-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

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, 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, 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

Outcome

Type Measure Description Time frame Safety issue
Primary Amblyopic vision Improvement in amblyopic vision : visual acuity and stereoacuity 9 months No
Secondary Spatial vision Improvement in spatial vision (positional acuity and spatial attention) 9 months No
Secondary Temporal vision Improvement in temporal processing and temporal vision (attentional blink) 9 months No
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