Binocular Visual Therapy and Video Games for Amblyopia Treatment.

Universidad Autonoma de Nuevo Leon

Status: Enrolling

Conditions: Amblyopia

Treatments: Device: Eye patch; Device: Red/green glasses; Device: Electronic Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03655912

OF17-00013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Patch

Active Comparator group

Description:

Eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc)

Treatment:

Device: Eye patch

Electronic Devices

Experimental group

Description:

Eye patch on the fellow eye and a electronic tablet

Treatment:

Device: Electronic Tablet

Red/Green Glasses

Experimental group

Description:

Red/green glasses and a electronic tablet

Treatment:

Device: Red/green glasses