AzTrials
AzTrials

AmblyopiaNCT06150391

Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program

A study testing Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks and Patching in people with Amblyopia, run by Hospital de Merida at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Interest in developing alternative methods for the treatment of amblyopia (lazy eye) has long been a topic of interest among clinicians and researchers. Occlusion or penalization of fellow eye do not always provide the desired visual acuity improvement. Read more about this study

Who is it for?
Ages 4 to 12 years
Conditions the study is for
Amblyopia
What is being tested?
Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks and Patching
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteSpain
Study dates
4 Dec 2023to 15 Oct 2026
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 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The sample will be made up of children with amblyopia from 4 to 12 years old (amblyopia will be defined as the best corrected visual acuity less o equal to 0.8 in decimal units or > 2 lines of difference between both eyes). Strabismus inclusion criteria will be < 25 prismatic diopters, with a deviation ≥ 2 prismatic diopters.

Who cannot join

  • Subjects with nystagmus, ocular pathology o cognitive delay will be excluded.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Servicio de Oftalmología del Hospital de Merida

    Mérida, Extremadura, 06800

Other trials in Spain

About this study

Official title: Randomized Controlled Trial of a Dichoptic Gabor Videogame Program to Improve Visual Function in Children With Amblyopia

Interest in developing alternative methods for the treatment of amblyopia (lazy eye) has long been a topic of interest among clinicians and researchers. Occlusion or penalization of fellow eye do not always provide the desired visual acuity improvement. Moreover, occlusion is associated with a high risk of recurrence and non-compliance. Here, it is presented a protocol of a randomized clinical trial to evaluate the safety and clinical efficacy of a novel home-based system, based on a computer game.

The goal of this prospective clinical trial is to compare in visual acuity improvements in patients with amblyopia, following conventional patching therapy or this novel computer-based therapy.

Read more

The main questions it aims to answer are:

  • Does computer-based therapy equal or improve patching therapy? Can it be used as an alternative to patching?
  • Does computer-based therapy used in combination with pathching solve amblyopia when patching fails alone (persistent amblyopia)?

Participants will be divided in two groups according to the previous occlusion o penalization of fellow eye. Both groups will be divided in two subgroups, experimental and control. Researchers will compare subgroups outcomes in order to asses this novel approach.

Read the detailed description

Amblyopia is a common neurodevelopmental abnormality that results in physiological alterations of the visual pathways and impaired vision in one eye or, less commonly, in both.Disruption of normal visual development early in life may result in perceptual, oculomotor and clinical abnormalities such as instability of fixation, anomalous retinal correspondence, and lack of stereoacuity.Amblyopia has a prevalence of around 2-4% in children and is associated with refractive error (anisometropia or isometropia) and strabismus.

The Pediatric Eye Disease Investigator Group (PEDIG) has produced several studies that analyze the most effective therapies for amblyopic eye. The gold standard treatment prescribed for this condition combines spectacle correction of the refractive error with penalization and/or occlusion of the dominant eye

Interest in developing alternative methods for the treatment of amblyopia (lazy eye) has long been a topic of interest among clinicians and researchers. Occlusion or penalization of fellow eye do not always provide the desired visual acuity improvement. Moreover, occlusion is associated with a high risk of recurrence and non-compliance.

This randomized clinical trial is designed to evaluate the safety and clinical efficacy of a novel home-based system, based on a computer activity that uses dichoptic Gabor Patches and band-filtered noise masks. It combines the concepts of perceptual learning, dichoptic training, home based therapy and gamification.

The goal of this prospective clinical trial is to compare in visual acuity improvements in patients with amblyopia, following conventional patching therapy or this novel computer-based therapy.

The main questions it aims to answer are:

  • Does computer-based therapy equal or improve patching therapy? Can it be used as an alternative to patching?
  • Does computer-based therapy used as coadjuvant to pathching solve amblyopia in patients where patching fails alone (persistent amblyopia)?

Participants will be divided in two groups according to the previous occlusion o penalization of fellow eye. Both groups will be divided in two subgroups, experimental and control. Researchers will compare subgroups outcomes in order to asses if this novel approach may lead to greater improvements in vision performance in amblyopic children as substitution of occlusion treatment in novel amblyopia or as coadjutant in persistent amblyopia.

Conditions
Amblyopia
Being tested
Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks, Patching
Keywords
amblyopia, perceptual learning, dichoptic therapy, visual acuity
Medical subject headings
Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masksDevice

    Visionary exercises are computer gammified activities that run on a computer with internet connection to facilitate home therapy. Patient must wear anaglyph glasses. Visual stimuli consists in dichoptic Gabor Patches presented to the amblyopic eye. Frequency is adjusted to actual patient visual acuity, and contrast to actual patient performance (contrast sensitivity). A band-filtered noise mask at the same frequency than the Gabor patch is presented to the fellow eye in certain ocassions.

  • PatchingDevice

    PEDIG (Pediatric Eye Disease Investigator Group) recommended amblyopia treatment. Consist on covering a child's better-seeing eye with a patch for 2 hours per day for mild and moderate amblyopia or 6 hours per day for severe amblyopia

Study groups in NCT06150391
Study groupRoleWhat they receive
Group GA-E. Patients without previous occlusion o penalization treatment - ExperimentalExperimentalGA-E volunteers (experimental) will be prescribed home therapy using computer-based exercises (Visionary) for 12 weeks, five days week, ½ half hour per day. Visionary target frequencies will be adjusted, considering BCVA, each three weeks. Contrast of Gabor patch frequencies will be adjusted to match patient contrast sensitivity thresholds. In case BCVA does not improve at least 2 lines in two consecutive visits (6 weeks), patients will change to GA-C.
Receives: Device: Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks
Group GA-C. Patients without previous occlusion o penalization treatment - ControlActive comparatorGA-C patients (control) will be prescribed occlusion following Pediatric Eye Disease Investigation Group (PEDIG) criteria: 2 hours for mild and moderate amblyopia or 6 hours for severe amblyopia. Patients will receive a calendar to track patching accomplishment. In case BCVA does not improve at least 2 lines in two consecutive visits (6 weeks), patients will change to GA-E.
Receives: Device: Patching
Group GB-E. Patients with previous occlusion o penalization treatment - ExperimentalExperimentalGB-E volunteers will receive occlusion following PEDIG criteria and will be prescribed home therapy using Visionary. Patients will receive a calendar to track patching accomplishment. Visionary target frequencies will be adjusted, considering BCVA, each three weeks.
Receives: Device: Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks; Device: Patching
Group GB-C. Patients with previous occlusion o penalization treatment - ControlActive comparatorGB-C volunteers will receive occlusion following PEDIG criteria and will be prescribed home therapy using Visionary. Patients will receive a calendar to track patching accomplishment. Visionary target frequencies will always be low, no matter patient VA. In case BCVA does not improve at least 2 lines in two consecutive visits (6 weeks), patients will be move to GB-E.
Receives: Device: Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks; Device: Patching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BCVA Best Corrected Visual Acuity

    Best Corrected Visual Acuity is the measurement of the ability to distinguish shapes and the details of objects at a given distance wearing full refraction. Different optotipes are used to measure clinically this ability (e.g. Snellen E, ETDRS, etc.). Refraction must be calculated under cyclopegia following PEDIG criteria. Crowding bars can be added to the optotypes.

    In this study, amblyopic eye BCVA will be measured using visual acuity chart ETDRS whitout crowding bars, in logarithmic scale.

    Measured: Treatment will last 12 weeks, with BCVA measurements every 2 weeks. The stability control post treatment will last 12 months, with BCVA controls at 3, 6 and 12 months.

Secondary outcomes (1)

  1. Stereoacuity

    In this stuty Randot Preschool Stereoacuity Test (Stereo Optical, Inc., Chicago, USA) will be used to asses stereoacuity in arc seconds. This is a random dot stereogram that measures global stereopsis (or cyclopean stereopsis) and does not contain monocular cues. Stereoacuity is measured at a constant distance of 40 cm.

    Measured: Treatment will last 12 weeks, with stereoacuity measurements every 2 weeks. The stability control post treatment will last 12 months, with stereoacuity controls at 3, 6 and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2023
  2. Study start4 Dec 2023
  3. Primary completion15 Oct 2026
  4. Study completion15 Oct 2026

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Participants will be divided in two groups: GA, 60 participants without previous occlusion treatment; GB, 60 participants with previous occlusion or penalization. In GA, participants will be assigned to an Experimental subgroup (GA-E) or to a Control subgroup (GA-C). GA-E volunteers will be prescribed computer-based exercises (Visionary). GA-C patients will be prescribed occlusion. In GB, all participants will receive occlusion. There will be two subgroups, Experimental (GB-E) and Control (GB-C), and both will be prescribed exercises using Visionary. In GB-E the computer will adjust Gabor patches frequency to visual acuity, as normal; but in GB-C Gabor frequencies will always be low. Importantly, those patients with deviations (10 to 25 prismatic diopters) will be assigned to experimental or treatment subgroups following an independent randomization.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06150391
Sponsor's protocol ID
CEI 046/23
Status last verified
Oct 2026
First submitted
13 Nov 2023
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Verghese P, McKee SP, Levi DM. Attention deficits in Amblyopia. Curr Opin Psychol. 2019 Oct;29:199-204. doi: 10.1016/j.copsyc.2019.03.011. Epub 2019 Mar 22.

    PubMed 31030000

  • Fu Z, Hong H, Su Z, Lou B, Pan CW, Liu H. Global prevalence of amblyopia and disease burden projections through 2040: a systematic review and meta-analysis. Br J Ophthalmol. 2020 Aug;104(8):1164-1170. doi: 10.1136/bjophthalmol-2019-314759. Epub 2019 Nov 8.

    PubMed 31704700

  • Chen AM, Cotter SA. The Amblyopia Treatment Studies: Implications for Clinical Practice. Adv Ophthalmol Optom. 2016 Aug;1(1):287-305. doi: 10.1016/j.yaoo.2016.03.007. No abstract available.

    PubMed 28435934

  • Birch EE. Amblyopia and binocular vision. Prog Retin Eye Res. 2013 Mar;33:67-84. doi: 10.1016/j.preteyeres.2012.11.001. Epub 2012 Nov 29.

    PubMed 23201436

  • Buckle M, Billington C, Shah P, Ferris JD. Treatment outcomes for amblyopia using PEDIG amblyopia protocols: a retrospective study of 877 cases. J AAPOS. 2019 Apr;23(2):98.e1-98.e4. doi: 10.1016/j.jaapos.2018.12.007. Epub 2019 Mar 30.

    PubMed 30935990

  • GIBSON EJ. Perceptual learning. Annu Rev Psychol. 1963;14:29-56. doi: 10.1146/annurev.ps.14.020163.000333. No abstract available.

    PubMed 13947716

  • Rodan A, Candela Marroquin E, Jara Garcia LC. An updated review about perceptual learning as a treatment for amblyopia. J Optom. 2022 Jan-Mar;15(1):3-34. doi: 10.1016/j.optom.2020.08.002. Epub 2020 Nov 24.

    PubMed 33243673

  • Polat U, Ma-Naim T, Belkin M, Sagi D. Improving vision in adult amblyopia by perceptual learning. Proc Natl Acad Sci U S A. 2004 Apr 27;101(17):6692-7. doi: 10.1073/pnas.0401200101. Epub 2004 Apr 19.

    PubMed 15096608

  • Polat U, Ma-Naim T, Spierer A. Treatment of children with amblyopia by perceptual learning. Vision Res. 2009 Oct;49(21):2599-603. doi: 10.1016/j.visres.2009.07.008. Epub 2009 Jul 19.

    PubMed 19622368

  • Barollo M, Contemori G, Battaglini L, Pavan A, Casco C. Perceptual learning improves contrast sensitivity, visual acuity, and foveal crowding in amblyopia. Restor Neurol Neurosci. 2017;35(5):483-496. doi: 10.3233/RNN-170731.

    PubMed 28800339

  • Levi DM, Li RW. Perceptual learning as a potential treatment for amblyopia: a mini-review. Vision Res. 2009 Oct;49(21):2535-49. doi: 10.1016/j.visres.2009.02.010. Epub 2009 Feb 27.

    PubMed 19250947

  • Chen PL, Chen JT, Fu JJ, Chien KH, Lu DW. A pilot study of anisometropic amblyopia improved in adults and children by perceptual learning: an alternative treatment to patching. Ophthalmic Physiol Opt. 2008 Sep;28(5):422-8. doi: 10.1111/j.1475-1313.2008.00588.x.

    PubMed 18761479

  • Stewart CE, Moseley MJ, Stephens DA, Fielder AR. Treatment dose-response in amblyopia therapy: the Monitored Occlusion Treatment of Amblyopia Study (MOTAS). Invest Ophthalmol Vis Sci. 2004 Sep;45(9):3048-54. doi: 10.1167/iovs.04-0250.

    PubMed 15326120

  • Baker DH, Meese TS, Mansouri B, Hess RF. Binocular summation of contrast remains intact in strabismic amblyopia. Invest Ophthalmol Vis Sci. 2007 Nov;48(11):5332-8. doi: 10.1167/iovs.07-0194.

    PubMed 17962490

  • 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.

    PubMed 25060850

Questions about this trial

What is this clinical trial studying?

A study testing Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks and Patching in people with Amblyopia, run by Hospital de Merida at 1 site in Spain.

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 1 inclusion and 1 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 20 Oct 2026. 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 Spain. 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. 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?

BCVA Best Corrected Visual Acuity (time frame: Treatment will last 12 weeks, with BCVA measurements every 2 weeks. The stability control post treatment will last 12 months, with BCVA controls at 3, 6 and 12 months.). 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 NCT06150391, which also lists 31 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 20 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in