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NCT Number: NCT03655912

Binocular Visual Therapy and Video Games for Amblyopia Treatment.

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.

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Monterrey, Nuevo León, 64460, Mexico

Location status: Recruiting

Location contact

Karim Mohamed-Noriega, M.D.

CONTACT

[email protected]

+52 81 83469259

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Red/green glasses

Device

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

Electronic Tablet

Device

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

Eye Patch

Device

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

Primary outcomes

  1. Best corrected visual acuity of the amblyopic eye

    Time frame: Basal

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

  2. Best corrected visual acuity of the amblyopic eye

    Time frame: One month of treatment

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

  3. Best corrected visual acuity of the amblyopic eye

    Time frame: Two months of treatment

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

  4. Best corrected visual acuity of the amblyopic eye

    Time frame: Three months of treatment

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

  5. Best corrected visual acuity of the amblyopic eye

    Time frame: Four months of treatment

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

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

    Time frame: Two months after treatment suspension.

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

Secondary outcomes

  1. Stereopsis

    Time frame: Basal

    Stereopsis measurement by titmus test

  2. Stereopsis

    Time frame: One month of treatment

    Stereopsis measurement by titmus test

  3. Stereopsis

    Time frame: Two months of treatment

    Stereopsis measurement by titmus test

  4. Stereopsis

    Time frame: Three months of treatment

    Stereopsis measurement by titmus test

  5. Stereopsis

    Time frame: Four months of treatment

    Stereopsis measurement by titmus test

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

    Time frame: Two months after treatment suspension.

    Stereopsis measurement by titmus test

Study contacts

Contact information is provided by the study sponsor or research team.

Marissa L. Fernandez-de Luna, MD

CONTACT

[email protected]

+528183469259

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2018
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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