Amblyopia Treatment for Children Aged 8 to 12 Years

NCT07281742 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-15

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281742 on ClinicalTrials.gov