NCT03655912 Binocular Visual Therapy and Video Games for Amblyopia Treatment.
| NCT ID | NCT03655912 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Autonoma de Nuevo Leon |
| Condition | Amblyopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2018-10-09 |
| Primary Completion | 2026-10 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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