Binocular Visual Therapy and Video Games for Amblyopia Treatment.

May 11, 2023 updated by: Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Recruiting
        • Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patch
Eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc)
Device: Eye patch
The use of eye patch on the fellow eye and near vision activities for 2 hours a day during 4 months.
Experimental: Electronic Devices
Eye patch on the fellow eye and a electronic tablet
Device: Electronic Tablet
The use of eye patch on the fellow eye and electronic tablet for 2 hours a day during 4 months.
Experimental: Red/Green Glasses
Red/green glasses and a electronic tablet
Device: Red/green glasses
The use of red/green glasses and electronic devices for two hours a day during 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Basal
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.
One month of treatment
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.
Two months of treatment
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.
Three months of treatment
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.
Four months of treatment
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.
Two months after treatment suspension.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stereopsis
Time Frame: Basal
Stereopsis measurement by titmus test
Basal
Stereopsis
Time Frame: One month of treatment
Stereopsis measurement by titmus test
One month of treatment
Stereopsis
Time Frame: Two months of treatment
Stereopsis measurement by titmus test
Two months of treatment
Stereopsis
Time Frame: Three months of treatment
Stereopsis measurement by titmus test
Three months of treatment
Stereopsis
Time Frame: Four months of treatment
Stereopsis measurement by titmus test
Four months of treatment
Stereopsis two months after treatment suspension to determine lazy eye relapses
Time Frame: Two months after treatment suspension.
Stereopsis measurement by titmus test
Two months after treatment suspension.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Nuevo Leon

Collaborators

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Marissa L. Fernandez-de Luna, MD, Universidad Autonoma de Nuevo Leon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2018

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OF17-00013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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