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Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games

Primary Purpose

Amblyopia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Game Vision Training
Perceptual Learning
Occlusion Therapy
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring perceptual learning, video games, visual plasticity, amblyopia treatment, pathophysiology of amblyopia, vision training, stereoacuity, strabismus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adults and children with normal vision or amblyopia
  • amblyopia: interocular VA difference of 0.1 logMAR or more

Exclusion Criteria:

  • any ocular pathological conditions, nystagmus

Sites / Locations

  • Nova Southeastern University College of OptometryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Video Games

Perceptual learning

Occlusion therapy

Arm Description

Participants will be required to play video games for a period of time: 1-2 hrs per session, 4-5 sessions/week for ~1-6 months

Participants will be required to practice a visual discrimination task (e.g. visual acuity, position acuity, contrast sensitivity, & stereoacuity) for a period of time: 1-2 hrs per session, 4-5 sessions/week for ~1-6 months

Participants will be required to cover the dominant eye during the day in order to push the brain to use the fellow amblyopic eye: 1-2 hrs per session, 4-5 sessions/week for ~1-6 months

Outcomes

Primary Outcome Measures

Change in visual acuity before and after the intervention
"Visual acuity", the gold standard for vision testing, will be measured. Participants will be asked to read letters on a LogMAR letter chart. The smallest letters that can be read correspond to visual acuity (e.g., Snellen acuity of 20/20, letter-stroke width = 1 minute of arc).
Change in stereoacuity before and after the intervention
"Stereoacuity" will be measured psychophysically using a new stereoacuity function test (1.25, 2.5, 5, 10, 15, & 20 cycles per degree) developed in our previous studies (Li et al 2016). A custom-built 4-mirror haploscope will be used to present a stereogram to each eye. Stereoacuity is the smallest stereo disparity that can be seen in binocular vision (in the unit of seconds of arc, arcsec). The conventional stereoacuity tests (including Randot Stereoacuity Test, Stereofly Test & Preschool Stereo Test) will also be used to measure stereoacuity. Participants will be asked to wear a pair of 3D glasses and to identify the target 3D pictures at various 3D levels. The smallest 3D disparities that can be seen correspond to stereoacuity (e.g. normal range of stereoacuity: 50 seconds of arc or better).

Secondary Outcome Measures

Change in contrast sensitivity before and after the intervention
"Contrast sensitivity", the ability to detect low contrast / brightness, will be measured psychophysically for a range of spatial frequencies (1.25, 2.5, 5, 10, & 20 cycles per degree). Visual stimuli at different contrast levels will be displayed on a monitor screen. The smallest detectable stimulus contrast level will be measured in the unit of cd/m2.
Change in positional (or Vernier) acuity before and after the intervention
"Positional acuity", the ability to detect a subtle positional offset between visual stimuli, will be measured psychophysically. Visual stimuli with different amount of positional offsets will be displayed on a monitor screen. The smallest detectable stimulus offset will be measured as position acuity, in the unit of seconds of arc.

Full Information

First Posted
August 24, 2022
Last Updated
September 13, 2022
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT05522972
Brief Title
Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games
Official Title
Improving Normal and Amblyopic Vision With Video Games and Perceptual Learning
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Southeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 Publications) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
perceptual learning, video games, visual plasticity, amblyopia treatment, pathophysiology of amblyopia, vision training, stereoacuity, strabismus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Video Games
Arm Type
Experimental
Arm Description
Participants will be required to play video games for a period of time: 1-2 hrs per session, 4-5 sessions/week for ~1-6 months
Arm Title
Perceptual learning
Arm Type
Experimental
Arm Description
Participants will be required to practice a visual discrimination task (e.g. visual acuity, position acuity, contrast sensitivity, & stereoacuity) for a period of time: 1-2 hrs per session, 4-5 sessions/week for ~1-6 months
Arm Title
Occlusion therapy
Arm Type
Active Comparator
Arm Description
Participants will be required to cover the dominant eye during the day in order to push the brain to use the fellow amblyopic eye: 1-2 hrs per session, 4-5 sessions/week for ~1-6 months
Intervention Type
Behavioral
Intervention Name(s)
Video Game Vision Training
Intervention Description
A new approach for improving amblyopic vision using video games
Intervention Type
Behavioral
Intervention Name(s)
Perceptual Learning
Intervention Description
A new approach for improving amblyopic vision with perceptual learning
Intervention Type
Behavioral
Intervention Name(s)
Occlusion Therapy
Intervention Description
Conventional treatment for amblyopia
Primary Outcome Measure Information:
Title
Change in visual acuity before and after the intervention
Description
"Visual acuity", the gold standard for vision testing, will be measured. Participants will be asked to read letters on a LogMAR letter chart. The smallest letters that can be read correspond to visual acuity (e.g., Snellen acuity of 20/20, letter-stroke width = 1 minute of arc).
Time Frame
9 months
Title
Change in stereoacuity before and after the intervention
Description
"Stereoacuity" will be measured psychophysically using a new stereoacuity function test (1.25, 2.5, 5, 10, 15, & 20 cycles per degree) developed in our previous studies (Li et al 2016). A custom-built 4-mirror haploscope will be used to present a stereogram to each eye. Stereoacuity is the smallest stereo disparity that can be seen in binocular vision (in the unit of seconds of arc, arcsec). The conventional stereoacuity tests (including Randot Stereoacuity Test, Stereofly Test & Preschool Stereo Test) will also be used to measure stereoacuity. Participants will be asked to wear a pair of 3D glasses and to identify the target 3D pictures at various 3D levels. The smallest 3D disparities that can be seen correspond to stereoacuity (e.g. normal range of stereoacuity: 50 seconds of arc or better).
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change in contrast sensitivity before and after the intervention
Description
"Contrast sensitivity", the ability to detect low contrast / brightness, will be measured psychophysically for a range of spatial frequencies (1.25, 2.5, 5, 10, & 20 cycles per degree). Visual stimuli at different contrast levels will be displayed on a monitor screen. The smallest detectable stimulus contrast level will be measured in the unit of cd/m2.
Time Frame
9 months
Title
Change in positional (or Vernier) acuity before and after the intervention
Description
"Positional acuity", the ability to detect a subtle positional offset between visual stimuli, will be measured psychophysically. Visual stimuli with different amount of positional offsets will be displayed on a monitor screen. The smallest detectable stimulus offset will be measured as position acuity, in the unit of seconds of arc.
Time Frame
9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adults and children with normal vision or amblyopia amblyopia: interocular VA difference of 0.1 logMAR or more Exclusion Criteria: any ocular pathological conditions, nystagmus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roger W Li, OD, PhD
Phone
954-262-1436
Email
wli@nova.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger W Li, OD, PhD
Organizational Affiliation
Nova Southeastern University College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Southeastern University College of Optometry
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Li, OD, PhD
Phone
954-262-1436
Email
wli@nova.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15330715
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. doi: 10.1167/4.6.7.
Results Reference
background
PubMed Identifier
19109504
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.
Results Reference
background
PubMed Identifier
17962456
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. doi: 10.1167/iovs.07-0324.
Results Reference
background
PubMed Identifier
16123415
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. doi: 10.1167/iovs.05-0286.
Results Reference
background
PubMed Identifier
25715870
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.
Results Reference
background
PubMed Identifier
21912514
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.
Results Reference
background
PubMed Identifier
29779684
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. No abstract available.
Results Reference
background
PubMed Identifier
26909178
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. eCollection 2016 Jan.
Results Reference
background
PubMed Identifier
27703690
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. doi: 10.1098/rsos.160273. eCollection 2016 Sep.
Results Reference
background
PubMed Identifier
14730311
Citation
Li RW, Levi DM, Klein SA. Perceptual learning improves efficiency by re-tuning the decision 'template' for position discrimination. Nat Neurosci. 2004 Feb;7(2):178-83. doi: 10.1038/nn1183. Epub 2004 Jan 18.
Results Reference
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Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games

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