At-home Curesight treatment for children 8 to 12 with amblyopia
Amblyopia Treatment for Children Aged 8 to 12 Years
This will test whether at-home Curesight dichoptic video therapy can improve vision in children aged 8–12 with amblyopia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | Retina Foundation of the Southwest Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT07281742 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Dallas, Texas
- Retina Foundation of the Southwest — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Eileen E Birch, PhD
- Email: ebirch@retinafoundation.org
- Phone: 12144771464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.