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Will Perceptual Learning Via Video Game Playing Improve Visual Acuity Stereopsis & Fixation Stability in Mild Amblyopes?

Primary Purpose

Amblyopia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Dichoptic video game in an i-Pod touch device
Video game in an i-Pod touch device
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring amblyopia, fixation stability, perceptual learning

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Best corrected VA in amblyopic eye ≤ 0.28 log MAR, fellow eye VA with an interocular VA difference ≥ 0.20 log MAR;
  • Amblyopia could be in form of strabismic, anisometropic and mixed (both strabismic and anisometropic)
  • Able to complete 3 successful measurements (each with 30 seconds fixation) of BCEA by the MP-1 systems in each eye
  • Able to align the nonius cross (≤10mm horizontal error and 5mm vertical error) in the i-Pod game

Exclusion Criteria:

  • Myopia of spherical equivalent power > -6.0 diopter in either eye
  • Previous intraocular surgery
  • any types of ocular pathology (e.g. media opacities or retinal lesion)
  • Previous or current history of neurological problem

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention (dichoptic video game play)

Control (video game play)

Arm Description

Mild amblyopic subjects will be asked to play dichoptic video game in an i-Pod touch device for 1 hour per day in 6 weeks.

Mild amblyopic subjects will be asked to play video game in an i-Pod touch device for 1 hour per day in 6 weeks.

Outcomes

Primary Outcome Measures

Change in fixation stability (in terms of Bivariate contour ellipse area in degree square) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes
Change in fixation stability (in terms of Bivariate contour ellipse area in degree square) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes. The 95% bivariate contour ellipse area will be adopted in units of degree square.

Secondary Outcome Measures

Change in best corrected visual acuity (in log MAR) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes
Change in best corrected visual acuity (in log MAR) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes. Best corrected visual acuity will be measured in log MAR unit.
Change in stereopsis (in arc sec) after 6 weeks dichoptic video game playing in mild amblyopes
Change in stereopsis (in arc sec) after 6 weeks dichoptic video game playing in mild amblyopes. The Titmus and Randot preschool stereopsis test will be used and the measurements are recorded in ' second of arc'.

Full Information

First Posted
December 14, 2016
Last Updated
August 2, 2020
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02995174
Brief Title
Will Perceptual Learning Via Video Game Playing Improve Visual Acuity Stereopsis & Fixation Stability in Mild Amblyopes?
Official Title
Will Perceptual Learning Via Video Game Playing Improve Visual Acuity, Stereopsis and Fixation Stability in Mild Amblyopes? Part 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Contrast balanced dichoptic videogame training has been found to improve sensory functions in adults with amblyopia; best corrected distance visual acuity (BCVA) and stereopsis, but its effect on motor function, namely amblyopic eye fixation stability, is unknown. Furthermore, the effect of treatment in cases of mild amblyopia is not well understood. The aim of this study is to find out the difference on fixation stability, BCVA and stereopsis in mild amblyopes after 6 weeks' contrast balanced dichoptic video game training.
Detailed Description
Objectives: To assess the change of fixation stability as well as visual acuity and stereopsis before and after training mild amblyopia by perceptual learning through dichoptic video game playing. Hypothesis: It has been shown that the visual acuity, stereopsis and fixation stability are compromised in amblyopic eye. Perceptual learning via video game playing has been found effective in improving visual acuity and stereoacuity in moderate and severe amblyopic eyes, but there is no study on such treatment in mild amblyopia. In this study, we hypothesize that fixation stability, visual acuity and stereopsis will be improved after training by dichoptic video game playing in mild amblyopia. Methods: Participants (aged 7 or above) with Best Corrected Visual Acuity (BCVA) ≤ 0.28 logMAR in the amblyopic eye and an interocular acuity difference ≥ 0.2 logMAR will be recruited. An anaglyphic, contrast balanced dichoptic video game will be provided on an i-Pod Touch (Apple Inc.) for 6 weeks of home-based training (60 mins per day). Fixation stability quantified using bivariate contour ellipse area (BCEA by micro-perimeter (MP) Nidek MP-1), BCVA and stereopsis will be assessed before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
amblyopia, fixation stability, perceptual learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (dichoptic video game play)
Arm Type
Experimental
Arm Description
Mild amblyopic subjects will be asked to play dichoptic video game in an i-Pod touch device for 1 hour per day in 6 weeks.
Arm Title
Control (video game play)
Arm Type
Placebo Comparator
Arm Description
Mild amblyopic subjects will be asked to play video game in an i-Pod touch device for 1 hour per day in 6 weeks.
Intervention Type
Device
Intervention Name(s)
Dichoptic video game in an i-Pod touch device
Intervention Description
Amblyope will wear a pair of red green goggles and play the video game with 'contrast-balanced' images displayed on the screen of an i-Pod touch device. The eye with weaker eyesight will see the image with high contrast, and the good eye will see the image with low contrast. The subject will play the game one hour per day for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Video game in an i-Pod touch device
Intervention Description
Amblyope will wear a pair of red green goggles and play the video game with equal contrast images displayed on the screen of an i-Pod touch device. Both eyes will see the image of same contrast. The subject will play the game one hour per day for 6 weeks.
Primary Outcome Measure Information:
Title
Change in fixation stability (in terms of Bivariate contour ellipse area in degree square) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes
Description
Change in fixation stability (in terms of Bivariate contour ellipse area in degree square) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes. The 95% bivariate contour ellipse area will be adopted in units of degree square.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in best corrected visual acuity (in log MAR) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes
Description
Change in best corrected visual acuity (in log MAR) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes. Best corrected visual acuity will be measured in log MAR unit.
Time Frame
6 weeks
Title
Change in stereopsis (in arc sec) after 6 weeks dichoptic video game playing in mild amblyopes
Description
Change in stereopsis (in arc sec) after 6 weeks dichoptic video game playing in mild amblyopes. The Titmus and Randot preschool stereopsis test will be used and the measurements are recorded in ' second of arc'.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Best corrected VA in amblyopic eye ≤ 0.28 log MAR, fellow eye VA with an interocular VA difference ≥ 0.20 log MAR; Amblyopia could be in form of strabismic, anisometropic and mixed (both strabismic and anisometropic) Able to complete 3 successful measurements (each with 30 seconds fixation) of BCEA by the MP-1 systems in each eye Able to align the nonius cross (≤10mm horizontal error and 5mm vertical error) in the i-Pod game Exclusion Criteria: Myopia of spherical equivalent power > -6.0 diopter in either eye Previous intraocular surgery any types of ocular pathology (e.g. media opacities or retinal lesion) Previous or current history of neurological problem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carly Lam, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25727578
Citation
Birch EE, Li SL, Jost RM, Morale SE, De La Cruz A, Stager D Jr, Dao L, Stager DR Sr. Binocular iPad treatment for amblyopia in preschool children. J AAPOS. 2015 Feb;19(1):6-11. doi: 10.1016/j.jaapos.2014.09.009.
Results Reference
background
PubMed Identifier
23791411
Citation
Birch EE, Subramanian V, Weakley DR. Fixation instability in anisometropic children with reduced stereopsis. J AAPOS. 2013 Jun;17(3):287-90. doi: 10.1016/j.jaapos.2013.03.011.
Results Reference
background
PubMed Identifier
25668775
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.
Results Reference
background
PubMed Identifier
22789926
Citation
Gonzalez EG, Wong AM, Niechwiej-Szwedo E, Tarita-Nistor L, Steinbach MJ. Eye position stability in amblyopia and in normal binocular vision. Invest Ophthalmol Vis Sci. 2012 Aug 9;53(9):5386-94. doi: 10.1167/iovs.12-9941.
Results Reference
background
PubMed Identifier
27756405
Citation
Guo CX, Babu RJ, Black JM, Bobier WR, Lam CS, Dai S, Gao TY, Hess RF, Jenkins M, Jiang Y, Kowal L, Parag V, South J, Staffieri SE, Walker N, Wadham A, Thompson B; BRAVO study team. Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial. Trials. 2016 Oct 18;17(1):504. doi: 10.1186/s13063-016-1635-3.
Results Reference
background
PubMed Identifier
25131694
Citation
Hess RF, Babu RJ, Clavagnier S, Black J, Bobier W, Thompson B. The iPod binocular home-based treatment for amblyopia in adults: efficacy and compliance. Clin Exp Optom. 2014 Sep;97(5):389-98. doi: 10.1111/cxo.12192. Epub 2014 Aug 18.
Results Reference
background
PubMed Identifier
25060850
Citation
Li SL, Jost RM, Morale SE, Stager DR, Dao L, Stager D, Birch EE. A binocular iPad treatment for amblyopic children. Eye (Lond). 2014 Oct;28(10):1246-53. doi: 10.1038/eye.2014.165. Epub 2014 Jul 25.
Results Reference
background
PubMed Identifier
26930079
Citation
Shaikh AG, Otero-Millan J, Kumar P, Ghasia FF. Abnormal Fixational Eye Movements in Amblyopia. PLoS One. 2016 Mar 1;11(3):e0149953. doi: 10.1371/journal.pone.0149953. eCollection 2016.
Results Reference
background
PubMed Identifier
23372053
Citation
Subramanian V, Jost RM, Birch EE. A quantitative study of fixation stability in amblyopia. Invest Ophthalmol Vis Sci. 2013 Mar 19;54(3):1998-2003. doi: 10.1167/iovs.12-11054.
Results Reference
background
PubMed Identifier
21335317
Citation
To L, Thompson B, Blum JR, Maehara G, Hess RF, Cooperstock JR. A game platform for treatment of amblyopia. IEEE Trans Neural Syst Rehabil Eng. 2011 Jun;19(3):280-9. doi: 10.1109/TNSRE.2011.2115255. Epub 2011 Feb 17.
Results Reference
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Will Perceptual Learning Via Video Game Playing Improve Visual Acuity Stereopsis & Fixation Stability in Mild Amblyopes?

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