AmblyopiaNCT02995174
Will Perceptual Learning Via Video Game Playing Improve Visual Acuity Stereopsis & Fixation Stability in Mild Amblyopes?
A study testing Dichoptic video game in an i-Pod touch device and Video game in an i-Pod touch device in people with Amblyopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Amblyopia
- What is being tested?
- Dichoptic video game in an i-Pod touch device and Video game in an i-Pod touch device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Amblyopia
- Being tested
- Dichoptic video game in an i-Pod touch device, Video game in an i-Pod touch device
- Keywords
- amblyopia, fixation stability, perceptual learning
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dichoptic video game in an i-Pod touch deviceDevice
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.
Video game in an i-Pod touch deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Video game in an i-Pod touch device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 6 weeks
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'.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startAug 2015
- Primary completion18 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly Lam, The Hong Kong Polytechnic University
- Investigators
- Carly Lam, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995174
- Sponsor's protocol ID
- HMRF11122991
- Status last verified
- Aug 2020
- First submitted
- 14 Dec 2016
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25727578Birch 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.
PubMed 23791411Chung 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.
PubMed 25668775Gonzalez 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.
PubMed 22789926Guo 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.
PubMed 27756405Hess 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.
PubMed 25131694Li 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.
PubMed 25060850Shaikh 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.
PubMed 26930079Subramanian 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.
PubMed 23372053To 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.
PubMed 21335317
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Perceptual Learning Via Video Game Playing Improve Visual Acuity, Stereopsis and Fixation Stability in Mild Amblyopes? Part 2 Study
- ClinicalTrials.gov ID
- NCT02995174
- Acronym / sponsor ID
- HMRF11122991
- Conditions
- Amblyopia
- Keywords
- amblyopia, fixation stability, perceptual learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (dichoptic video game play) | Experimental | Device: Dichoptic video game in an i-Pod touch deviceMild amblyopic subjects will be asked to play dichoptic video game in an i-Pod touch device for 1 hour per day in 6 weeks. |
| Control (video game play) | Placebo comparator | Device: Video game in an i-Pod touch deviceMild amblyopic subjects will be asked to play video game in an i-Pod touch device for 1 hour per day in 6 weeks. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dichoptic video game in an i-Pod touch deviceAmblyope 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. | Device | Intervention (dichoptic video game play) |
| Video game in an i-Pod touch deviceAmblyope 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. | Device | Control (video game play) |
Primary outcome
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.
2 secondary outcomes
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 stereopsis (in arc sec) after 6 weeks dichoptic video game playing in mild amblyopes
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Background: PubMed 25727578Birch 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.
- Background: PubMed 23791411Birch 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.
- Background: PubMed 25668775Chung 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.
- Background: PubMed 22789926Gonzalez 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.
- Background: PubMed 27756405Guo 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.
- Background: PubMed 25131694Hess 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.
- Background: PubMed 25060850Li 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.
- Background: PubMed 26930079Shaikh 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.
- Background: PubMed 23372053Subramanian 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.
- Background: PubMed 21335317To 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carly Lam, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dichoptic video game in an i-Pod touch device and Video game in an i-Pod touch device in people with Amblyopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995174, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.