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

NCT02995174 | Completed DMC

• 1 other identifier: HMRF11122991
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia

Keywords

amblyopia; fixation stability; perceptual learning

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• Change in best corrected visual acuity (in log MAR) in the amblyopic eye after 6 weeks dichoptic video game playing in mild amblyopes

  6 weeks

• Change in stereopsis (in arc sec) after 6 weeks dichoptic video game playing in mild amblyopes

  6 weeks

Study Arms (2)

Intervention (dichoptic video game play)

EXPERIMENTAL

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

Control (video game play)

PLACEBO COMPARATOR

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

Interventions

Dichoptic video game in an i-Pod touch device 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 (dichoptic video game play)

Video game in an i-Pod touch device 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.

Control (video game play)

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (10)

• 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.

  PMID: 25727578 BACKGROUND

• 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.

  PMID: 23791411 BACKGROUND

• 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.

  PMID: 25668775 BACKGROUND

• 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.

  PMID: 22789926 BACKGROUND

• 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.

  PMID: 27756405 BACKGROUND

• 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.

  PMID: 25131694 BACKGROUND

• 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.

  PMID: 25060850 BACKGROUND

• 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.

  PMID: 26930079 BACKGROUND

• 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.

  PMID: 23372053 BACKGROUND

• 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.

  PMID: 21335317 BACKGROUND

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carly Lam, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: August 1, 2015
• Primary Completion: December 18, 2017
• Study Completion: December 31, 2018
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)