Amblyopia Treatment for Children Aged 8 to 12 Years

NCT07281742 | Recruiting FDA Device

• 1 other identifier: STU 2024-0924
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

amblyopia; dichoptic; children

Outcome Measures

Primary Outcomes (1)

• Improvement in best-corrected visual acuity of the amblyopic eye compared with baseline best-corrected visual acuity.

  Change in logMAR best-corrected visual acuity of the amblyopic eye compared with baseline best-corrected visual acuity.

  12 weeks

Study Arms (1)

Treatment with Curesight videos

EXPERIMENTAL

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.

Device: Curesight dichoptic videos

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.

Treatment with Curesight videos

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Retina Foundation of the Southwest: lead

Study Sites (1)

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eileen E Birch, PhD

CONTACT

12144771464; ebirch@retinafoundation.org

Reed M Jost, MS

CONTACT

2143633911; reedjost@retinafoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 15, 2025
• Study Start: January 7, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)