Recruiting

Curesight™

Sponsor:

Retina Foundation of the Southwest

Code:

NCT07281742

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

Interventions

Curesight dichoptic videos

Study Details

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

Study ID

NCT07281742

Start date

Jan 7, 2025

Status verified date

Dec, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 and Locations

Central contacts

Eileen E Birch, PhD

12144771464ebirch@retinafoundation.org

Reed M Jost, MS

2143633911reedjost@retinafoundation.org

Locations

Retina Foundation of the Southwest

Recruiting

Dallas, Texas, United States, 75231

Contacts

Eileen CEO

214-363-3911kcsaky@retinafoundation.org

Reed M Jost, MS

2143633911reedjost@retinafoundation.org

More Information

Sponsor

Retina Foundation of the Southwest

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • amblyopia
  • dichoptic
  • children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Retina Foundation of the Southwest on 2025-12-15.