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

August 2, 2020 updated by: Carly Lam, The Hong Kong Polytechnic University

Will Perceptual Learning Via Video Game Playing Improve Visual Acuity, Stereopsis and Fixation Stability in Mild Amblyopes? Part 2 Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (dichoptic video game play)
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.
Device: Dichoptic video game in an i-Pod touch device
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.
Placebo Comparator: Control (video game play)
Mild amblyopic subjects will be asked to play video game in an i-Pod touch device for 1 hour per day in 6 weeks.
Device: Video game in an i-Pod touch device
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in best corrected visual acuity (in log MAR) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes
Time Frame: 6 weeks
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.
6 weeks
Change in stereopsis (in arc sec) after 6 weeks dichoptic video game playing in mild amblyopes
Time Frame: 6 weeks
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'.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Carly Lam, PhD, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 18, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 16, 2016

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 2, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMRF11122991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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