RecruitingNot ApplicableNCT07281742

Amblyopia Treatment for Children Aged 8 to 12 Years

Sponsor

Retina Foundation of the Southwest

Enrollment

30 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Amblyopia

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

Min Age: 8 YearsMax Age: 12 Years

Inclusion Criteria7

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 Criteria5

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)

Interested in this trial?

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Interventions

DEVICECuresight dichoptic videos

Streamed videos are converted into 2 anaglyph channels, blue images for the amblyopic eye and red images for the fellow eye, and are presented superimposed. The stronger eye has blur imposed in the central visual area; the weaker amblyopic eye channel is not affected by the blur.