NCT03655912

Binocular Visual Therapy and Video Games for Amblyopia Treatment.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universidad Autonoma de Nuevo Leon · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-09
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2018-08-31
• Last updated: 2024-05-08

Locations

1 site across 1 country: Mexico