Actively Recruiting

Phase Not Applicable
Age: 4Years - 10Years
All Genders
ID03655912

Binocular Visual Therapy and Video Games for Amblyopia Treatment in Children Aged 4 to 10 Years

Led by Universidad Autonoma de Nuevo Leon · Updated on 2026-05-06

60

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

Universidad Autonoma de Nuevo Leon

Lead Sponsor

H

Hospital Universitario Dr. Jose E. Gonzalez

Collaborating Sponsor

AI-Summary

What this Trial Is About

Amblyopia, also known as lazy eye, is a condition where one or both eyes have reduced vision that cannot be explained by an eye abnormality alone. It causes problems with contrast perception, movement detection, visual sharpness, focusing, and depth perception. Traditionally, treatment involves patching the stronger eye for two hours daily, but this can have compliance issues and vision often regresses after stopping treatment. Recent research suggests amblyopia may involve both eyes due to changes in brain visual pathways, leading to new binocular treatments that aim to improve vision in the lazy eye and restore depth perception. This study compares three treatment methods in children with amblyopia aged 4 to 10 years: Group A uses an eye patch on the stronger eye with near-vision activities like reading and drawing; Group B uses an eye patch on the stronger eye combined with an electronic tablet; Group C uses red-green glasses with an electronic tablet. Each group receives their assigned treatment for two hours every day over four months, followed by a two-month break to assess if vision problems return. Participants will have their vision and depth perception tested at the start, monthly during treatment, and two months after stopping treatment to check for relapse. The study will measure the best corrected visual acuity in the lazy eye and stereopsis at these times. The trial is double-blind and randomized, aiming to find which treatment helps improve vision and binocular function the most. The total involvement lasts about six months, including treatment and follow-up evaluations.

CONDITIONS

Brief Title

Binocular Visual Therapy and Video Games for Amblyopia Treatment.

Who Can Participate

Age: 4Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with anisometropic amblyopia, strabismic amblyopia, or both
  • Patients without previous amblyopia treatment
  • Patients with previous strabismus surgery or use of best corrected visual acuity glasses for at least 1 month
  • Birth at term gestational age
  • Without any systemic or ophthalmic comorbidities
  • Parent verbal and fiscal assessment completed
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 months

Participants receive binocular visual therapy or eye patch treatment daily for 2 hours over 4 months using red/green glasses, electronic tablets, or near-vision activities depending on group assignment.

Monthly visits for 4 months

Follow-up

Duration - 2 months

Participants suspend therapy for 2 months and are reevaluated to assess for lazy eye relapses and improvements in vision.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico, 64460

Actively Recruiting

Loading map...

Research Team

M

Marissa L. Fernandez-de Luna, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years.

Vijay Tailor, Manuela Bossi, Catey Bunce...

https://pubmed.ncbi.nlm.nih.gov/26263202

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.

J Carlton, J Karnon, C Czoski-Murray...

https://pubmed.ncbi.nlm.nih.gov/18513466

Effects of anisometropic amblyopia on visuomotor behavior, III: Temporal eye-hand coordination during reaching.

Ewa Niechwiej-Szwedo, Herbert C Goltz, Manokaraananthan Chandrakumar...

https://pubmed.ncbi.nlm.nih.gov/21540479