At-home Curesight treatment for children 8 to 12 with amblyopia
Official title: Amblyopia Treatment for Children Aged 8 to 12 Years
Run by Retina Foundation of the Southwest · NCT07281742 · Data updated 2026-11-12
This will test whether at-home Curesight dichoptic video therapy can improve vision in children aged 8–12 with amblyopia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 12 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Retina Foundation of the Southwest Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | January 7, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | December 15, 2025 |
| Trial ID | NCT07281742 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 8–12 with amblyopic eye visual acuity ≤ 1.0 logMAR, an interocular difference ≥ 0.3 logMAR, corrected anisometropia/strabismus ≤ 5 pd, wearing glasses ≥ 8 weeks, and not currently using standard amblyopia treatments are ideal candidates.
✕Probably not a fit
Children with prematurity >8 weeks, coexisting ocular or systemic disease, developmental delay, light-induced epilepsy, or eye conditions that interfere with eye tracking are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Curesight delivers dichoptic video content so the amblyopic eye sees the full image while the fellow eye sees a partially blurred image to encourage binocular use. This pilot interventional study enrolls children 8–12 years with persistent amblyopia after standard care, who will be fitted and assessed at the Retina Foundation of the Southwest and then use the device at home. Visual acuity and binocular function will be measured before and after the intervention to determine if vision improves. The device has prior FDA clearance for children as young as 4 and shown efficacy in younger cohorts, but its effect in older children with residual amblyopia is being tested here.
Why it matters
Potential benefit: If successful, this could improve vision and binocular function in older children with persistent amblyopia and reduce lifelong visual disability.
How similar studies have gone: Randomized trials and a prior pivotal study have shown dichoptic binocular treatments and Curesight can be effective in younger children and Curesight has FDA clearance for ages 4+, but its effectiveness in 8–12-year-olds is less established.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Retina Foundation of the Southwest
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Eileen E Birch, PhD
- Email: ebirch@retinafoundation.org
- Phone: 12144771464
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.