Amblyopia Treatment for Children Aged 8 to 12 Years
NCT07281742 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-12-15
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.
Conditions
- Amblyopia
Interventions
- DEVICE
-
Curesight 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.
Sponsors & Collaborators
-
Retina Foundation of the Southwest
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-01-07
- Primary Completion
- 2027-12-31
- Completion
- 2028-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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