An Active Approach to Treat Amblyopia: Perceptual Learning and Video Games
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| First Received Date ICMJE | May 3, 2010 | ||||||||
| Last Updated Date | September 27, 2010 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Amblyopic vision [ Time Frame: 9 months ] [ Designated as safety issue: No ] Improvement in amblyopic vision : visual acuity and stereoacuity |
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| Original Primary Outcome Measures ICMJE |
Improvement in spatial and stereo vision [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01115283 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | An Active Approach to Treat Amblyopia: Perceptual Learning and Video Games | ||||||||
| Official Title ICMJE | Improving Spatial and Temporal Vision in Adult and Juvenile Amblyopia | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Amblyopia | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Experimental: Perceptual learning
Interventions:
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | May 2015 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01115283 | ||||||||
| Other Study ID Numbers ICMJE | R01EY01728, R01EY001728 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Roger W. Li/Associate Specialist, University of California, Berkeley | ||||||||
| Study Sponsor ICMJE | University of California, Berkeley | ||||||||
| Collaborators ICMJE | National Eye Institute (NEI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, Berkeley | ||||||||
| Verification Date | September 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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