Amblyopia Treatment for Children Aged 8 to 12 Years

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 12
Healthy Volunteers: t
View:

• 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

Locations
United States
Texas
Retina Foundation of the Southwest
RECRUITING
Dallas
Contact Information
Primary
Eileen E Birch, PhD
ebirch@retinafoundation.org
12144771464
Backup
Reed M Jost, MS
reedjost@retinafoundation.org
2143633911
Time Frame
Start Date: 2025-01-07
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 30
Treatments
Experimental: Treatment with Curesight videos
with this IRB application), indicated for improvement in visual acuity and stereo acuity in amblyopia patients, aged 4 - \<9 years, associated with anisometropia and/or with mild strabismus. This approval was based on data from a pilot study and a multi-center randomized clinical trial conducted with children aged 4 to 8 years.25,26 However, very few children older than age 7 years were included so the effectiveness of Curesight™ treatment for children aged 8 to 12 is unknown. Our pilot study will evaluate response to the Curesight™ treatment in this older age range.
Related Therapeutic Areas
Sponsors
Leads: Retina Foundation of the Southwest

This content was sourced from clinicaltrials.gov