Actively Recruiting

Phase Not Applicable
Age: 8Years - 12Years
All Genders
Healthy Volunteers
ID07281742

Amblyopia Treatment for Children Aged 8 to 12 Years Using Curesight12 Device

Led by Retina Foundation of the Southwest · Updated on 2025-12-15

30

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of at-home amblyopia treatment with Curesight12 for children aged 8 to 12 years who have residual amblyopia. Amblyopia, or lazy eye, is a vision disorder where the brain doesn't process images well from one eye, leading to decreased vision. While treatments like glasses and patching help younger children, many older children still experience vision problems, so new treatments for this age group are needed to improve quality of life and reduce lifelong vision risks. The treatment uses the Curesight12 system, which includes an 11.6-inch tablet, an eye tracker, red-cyan glasses, and software that streams videos with special visual effects to encourage the amblyopic eye to work better. Children watch videos of their choice at home while the system blurs part of the stronger eye's view to stimulate the weaker eye. The device adjusts the blur based on each child's vision, and the study will assess how effective this approach is for older children aged 8 to 12. Participants will be involved for at least 12 weeks, during which researchers will measure improvements in the visual acuity of the amblyopic eye compared to their starting vision. The study includes eye exams and vision tests to monitor progress and to adjust the treatment as needed. Data is securely stored and managed following privacy standards. This pilot study follows previous trials in younger children and aims to provide insight into Curesight12's benefits for this older age group.

CONDITIONS

Brief Title

Amblyopia Treatment for Children Aged 8 to 12 Years

Who Can Participate

Age: 8Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female and male children with amblyopia aged 8 to 12 years inclusive
  • Amblyopic eye visual acuity between 20/32 and 20/200 (\u2264 1.0 logMar)
  • Interocular difference in visual acuity of 0.3 logMAR or more
  • Anisometropia or strabismus corrected to less than 5 prism diopters
  • Wearing glasses for at least 8 weeks if needed
  • Not currently using standard-of-care treatments for amblyopia
  • Informed consent provided
Not Eligible

You will not qualify if you...

  • Prematurity greater than 8 weeks
  • Coexisting ocular or systemic disease
  • Developmental delay
  • History of light-induced epilepsy
  • Eye conditions that interfere with eye tracking, such as nystagmus, wearing rigid gas permeable contact lenses, paralysis of extraocular muscles, neurological conditions restricting eye movements, or ptosis covering the pupil

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 12 weeks

Participants watch streamed dichoptic videos using the Curesight device to treat amblyopia in the amblyopic eye by encouraging the brain to use sharp visual information from that eye.

Weekly visits for up to 12 weeks

Trial Site Locations

Total: 1 location

1

Retina Foundation of the Southwest

Dallas, Texas, United States, 75231

Actively Recruiting

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Research Team

E

Eileen E Birch, PhD

R

Reed M Jost, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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