Amblyopia Treatment for Children Aged 8 to 12 Years

Part of paid clinical trials in Dallas, Texas.

Sponsor
Retina Foundation of the Southwest
Study ID
NCT07281742
Status
Recruiting
Apply to this trial

Conditions

  • Amblyopia

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Curesight dichoptic videos — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 7, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Improvement in best-corrected visual acuity of the amblyopic eye compared with baseline best-corrected visual acuity. [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Foundation of the SouthwestDallasTexas75231
Eileen CEO
[email protected]
214-363-3911
Reed M Jost, MS
[email protected]
2143633911

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By research site
Retina Foundation of the Southwest· Dallas, TX

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