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Recruiting NCT07281742

Amblyopia Treatment for Children Aged 8 to 12 Years

Trial Parameters

Condition Amblyopia
Sponsor Retina Foundation of the Southwest
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 8 Years
Max Age 12 Years
Start Date 2025-01-07
Completion 2027-12-31
Interventions
Curesight dichoptic videos

Brief Summary

This study is being done to assess the effect of at-home amblyopia treatment with Curesight™ for children aged 8 to 12 years. Curesight™ allows you to stream any videos on a computer screen at home but the amblyopic eye will see the entire screen clearly while part of the image will be blurred for the other eye. There is already a pivotal clinical trial showing that this treatment is effective for young children and Curesight™ has been cleared for use as an amblyopia treatment by the FDA for children as young as 4 years.

Eligibility Criteria

Inclusion Criteria: * Female and male children with amblyopia age 8-12 years inclusive * Amblyopic eye visual acuity ≤ 1.0 logMar (20/32-20/200) * Interocular difference in visual acuity of 0.3 logMAR or more * Anisometropia or strabismus corrected to \<5 pd * Wearing glasses (if needed) ≥8 weeks * No longer using standard-of-care treatments for amblyopia * Informed consent Exclusion Criteria: * Prematurity \>8 weeks * Coexisting ocular or systemic disease * Developmental delay * History of light-induced epilepsy * Eye conditions that interfere with eye tracking (nystagmus, wearing RGP contact lenses, paralysis of the extra ocular muscles or any neurological condition that restricts eye movements, ptosis that covers the pupil)

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