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RecruitingNCT03655912Updated May 6, 2026

Binocular Visual Therapy and Video Games for Amblyopia Treatment.

An interventional study of Red/green glasses and Electronic Tablet in Amblyopia, sponsored by Universidad Autonoma de Nuevo Leon. Recruiting at 1 site in Mexico. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Universidad Autonoma de Nuevo Leon · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2018; still recruiting 8 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study summary

Amblyopia, or lazy eye, is best defined by the American Academy of Ophthalmology as a unilateral or bilateral reduction of the best corrected visual acuity that occurs in the setting of an otherwise normal eye, or a structural abnormality involving the eye or visual pathway with reduction in visual acuity that cannot be attributed only to the effect of the structural abnormality. Which causes an abnormal visual experience early in life, with consequences such as deficiencies in the ability to perceive contrast and/or movement, visual acuity, accommodation and stereopsis. The treatment of choice consists in patching of the fellow eye 2 hours per day. The disadvantage of this treatment modality is that patients end up not complying and when treatment is interrupted, lazy eye reappears. Amblyopia was thought to be a monocular disease, now a days there are reports of cortical visual paths changes in both eyes (the fellow and amblyopia eye), believing that it might be a monocular consequence of a binocular disease. Following that statement new treatment studies have arisen, stimulating both eyes not only to improve visual acuity in the lazy eye, but to restore binocular function as well. These treatments use videogames in celular phones, computers, or tablets where the fellow eye is exposed to reduced contrast and the lazy eye is exposed to full-contrast. Although the evidence is promising, more studies are needed to establish effectivity and security of this treatment modality.

Read the detailed description

The objective of this study is to determine if the binocular visual therapy with red-green glasses and the use of electronic devices is effective for amblyopia treatment in children.

Participants will be randomly assigned to one of three treatment modalities: Group A: eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc) Group B: an eye patch on the fellow eye and a electronic tablet Group C: red/green glasses and a electronic tablet

Treatment will be done buy the three groups daily during 2 consecutive hours, and will be completed for four months. Children will then suspend the therapy for 2 months, and will be reevaluated to determine lazy eye relapses . All groups will be compared to see which patients achieved greater improvement on visual acuity and depth perception.

02

Conditions studied

  • Amblyopia

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Keywords

  • Amblyopia
  • Binocular therapy
  • Videogames
03

In context

Amblyopia

189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 137 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Universidad Autonoma de Nuevo Leon is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with anisometropic amblyopia, strabismic amblyopia or both
  • Patients with out previous amblyopia treatment
  • Patient with previous strabismus surgery or use of there best corrected visual acuity glasses for at least 1 month
  • Birth at term gestational age
  • Without any systemic or ophthalmic comorbidities
  • Previous patients parent verbal and fiscal assessment.

Exclusion criteria

Exclusion Criteria:

  • Any other amblyopia diagnosis (deprivation)
  • Any previous amblyopia treatment
  • Any previous intraocular surgery
  • Any ocular condition
  • Any neurologic conditions or psychomotor development alterations
  • Patients not able to cooperate for visual acuity or stereopsis evaluation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Patch

    Eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc)

    Device: Eye patch

  • Experimental
    Electronic Devices

    Eye patch on the fellow eye and a electronic tablet

    Device: Electronic Tablet

  • Experimental
    Red/Green Glasses

    Red/green glasses and a electronic tablet

    Device: Red/green glasses

Interventions

  • DeviceRed/green glasses

    The use of red/green glasses and electronic devices for two hours a day during 4 months.

  • DeviceElectronic Tablet

    The use of eye patch on the fellow eye and electronic tablet for 2 hours a day during 4 months.

  • DeviceEye patch

    The use of eye patch on the fellow eye and near vision activities for 2 hours a day during 4 months.

06

What researchers measure

Primary outcomes

  1. Best corrected visual acuity of the amblyopic eye

    Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

    Time frame: Basal

  2. Best corrected visual acuity of the amblyopic eye

    Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

    Time frame: One month of treatment

  3. Best corrected visual acuity of the amblyopic eye

    Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

    Time frame: Two months of treatment

  4. Best corrected visual acuity of the amblyopic eye

    Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

    Time frame: Three months of treatment

  5. Best corrected visual acuity of the amblyopic eye

    Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

    Time frame: Four months of treatment

  6. Best corrected visual acuity of the amblyopic eye two months after treatment suspension to determine lazy eye relapses

    Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

    Time frame: Two months after treatment suspension.

Secondary outcomes

  1. Stereopsis

    Stereopsis measurement by titmus test

    Time frame: Basal

  2. Stereopsis

    Stereopsis measurement by titmus test

    Time frame: One month of treatment

  3. Stereopsis

    Stereopsis measurement by titmus test

    Time frame: Two months of treatment

  4. Stereopsis

    Stereopsis measurement by titmus test

    Time frame: Three months of treatment

  5. Stereopsis

    Stereopsis measurement by titmus test

    Time frame: Four months of treatment

  6. Stereopsis two months after treatment suspension to determine lazy eye relapses

    Stereopsis measurement by titmus test

    Time frame: Two months after treatment suspension.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Tailor V, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. Cochrane Database Syst Rev. 2015 Aug 11;2015(8):CD011347. doi: 10.1002/14651858.CD011347.pub2. PubMed 26263202 ↗
  • Kelly KR, Jost RM, Dao L, Beauchamp CL, Leffler JN, Birch EE. Binocular iPad Game vs Patching for Treatment of Amblyopia in Children: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1402-1408. doi: 10.1001/jamaophthalmol.2016.4224. PubMed 27832248 ↗
  • Hunter D. Amblyopia: The clinician's view. Vis Neurosci. 2018 Jan;35:E011. doi: 10.1017/S0952523817000189. No abstract available. PubMed 29905115 ↗
  • Carlton J, Karnon J, Czoski-Murray C, Smith KJ, Marr J. The clinical effectiveness and cost-effectiveness of screening programmes for amblyopia and strabismus in children up to the age of 4-5 years: a systematic review and economic evaluation. Health Technol Assess. 2008 Jun;12(25):iii, xi-194. doi: 10.3310/hta12250. PubMed 18513466 ↗
  • Grant S, Melmoth DR, Morgan MJ, Finlay AL. Prehension deficits in amblyopia. Invest Ophthalmol Vis Sci. 2007 Mar;48(3):1139-48. doi: 10.1167/iovs.06-0976. PubMed 17325157 ↗
  • Grant S, Moseley MJ. Amblyopia and real-world visuomotor tasks. Strabismus. 2011 Sep;19(3):119-28. doi: 10.3109/09273972.2011.600423. PubMed 21870915 ↗
  • Hrisos S, Clarke MP, Kelly T, Henderson J, Wright CM. Unilateral visual impairment and neurodevelopmental performance in preschool children. Br J Ophthalmol. 2006 Jul;90(7):836-8. doi: 10.1136/bjo.2006.090910. Epub 2006 Mar 15. PubMed 16540485 ↗
  • Niechwiej-Szwedo E, Goltz HC, Chandrakumar M, Hirji Z, Wong AM. Effects of anisometropic amblyopia on visuomotor behavior, III: Temporal eye-hand coordination during reaching. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5853-61. doi: 10.1167/iovs.11-7314. PubMed 21540479 ↗
  • O'Connor AR, Birch EE, Anderson S, Draper H; FSOS Research Group. The functional significance of stereopsis. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):2019-23. doi: 10.1167/iovs.09-4434. Epub 2009 Nov 20. PubMed 19933184 ↗
  • Rahi JS, Cumberland PM, Peckham CS. Does amblyopia affect educational, health, and social outcomes? Findings from 1958 British birth cohort. BMJ. 2006 Apr 8;332(7545):820-5. doi: 10.1136/bmj.38751.597963.AE. Epub 2006 Mar 6. PubMed 16520328 ↗
  • Webber AL, Wood JM, Gole GA, Brown B. The effect of amblyopia on fine motor skills in children. Invest Ophthalmol Vis Sci. 2008 Feb;49(2):594-603. doi: 10.1167/iovs.07-0869. PubMed 18235004 ↗
  • 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. PubMed 27756405 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03655912
Lead sponsor
Universidad Autonoma de Nuevo Leon
Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Responsible party
Karim Mohamed-Noriega (Professor, Universidad Autonoma de Nuevo Leon) — Principal investigator
First posted
Aug 31, 2018
Start date
Oct 9, 2018
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 6, 2026

Study contacts

Marissa L. Fernandez-de Luna, MD
Contact
dra.fernandezdeluna@gmail.com
+528183469259
Marissa L. Fernandez-de Luna, MD
principal investigator · Universidad Autonoma de Nuevo Leon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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