Binocular Visual Therapy and Video Games for Amblyopia Treatment.

NCT03655912 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-06

No results posted yet for this 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.

Conditions

  • Amblyopia

Interventions

DEVICE

Red/green glasses

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

DEVICE

Electronic Tablet

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

DEVICE

Eye patch

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

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    collaborator OTHER
  • Universidad Autonoma de Nuevo Leon

    lead OTHER

Principal Investigators

  • Marissa L. Fernandez-de Luna, MD · Universidad Autonoma de Nuevo Leon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-09
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655912 on ClinicalTrials.gov