Amblyopia Treatment for Children Aged 8 to 12 Years
Retina Foundation of the Southwest
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.
Description
Amblyopia (lazy eye) is a developmental vision disorder in which the brain doesn't efficiently process images from one eye and which over time causes decreased vision in that eye. Early detection and early treatment, by age 7 years, are effective in reducing the burden of amblyopia. There is evidence from randomized clinical trials (RCTs) that 73-90% of amblyopic children in this age range treated with glasses and patching, the most commonly prescribed treatments for amblyopia, have improvements in visual acuity. More recently, binocular amblyopia treatments show similar effectiveness to patch…
Eligibility
- Age range
- 8–12 years
- Sex
- All
- Healthy volunteers
- Yes
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 cont…
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.
Location
- Retina Foundation of the SouthwestDallas, Texas