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

NCT ID: NCT02995174

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Amblyopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dichoptic video game in an i-Pod touch device

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Video game in an i-Pod touch device

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Carly Lam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carly Lam, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type BACKGROUND
PMID: 25727578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23791411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25668775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22789926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27756405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25131694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25060850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26930079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23372053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21335317 (View on PubMed)

Other Identifiers

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HMRF11122991

Identifier Type: -

Identifier Source: org_study_id

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