Binocular Visual Therapy and Video Games for Amblyopia Treatment.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Binocular Visual Therapy and Video Games for Amblyopia Treatment.

Conditions
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Amblyopia

Intervention / Treatment
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* Device: Red/green glasses
* Device: Electronic Tablet
* Device: Eye patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amblyopia, Binocular therapy, Videogames