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Non-invasive Induction of Metaplasticity for Amblyopia
Sponsor: Boston Children's Hospital
Summary
The goal of this clinical trial is to determine the efficacy of flicker therapy as an adjunct therapy to treat amblyopia beyond the critical period in adolescents and adults aged 14-40 years who have amblyopia of ≥3 lines of interocular best-corrected (with glasses) visual acuity difference. The main questions it aims to answer are: * Does flicker therapy enable clinically meaningful and durable visual recovery from amblyopia? * Do flicker therapy-treated patients show a change in amblyopic eye visual acuity (lines)? Participants will undergo daily flicker therapy for 1 hour per day.
Official title: Non-invasive Induction of Metaplasticity to Treat Amblyopia in Adolescent and Adult Patients
Key Details
Gender
All
Age Range
14 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-11
Completion Date
2027-03
Last Updated
2026-09-29
Healthy Volunteers
No
Interventions
Flicker
The device is intended for investigational use in children (14 years old and up) and adults with amblyopia to evaluate the once daily use (up to 2 hours) over the study period of 8 weeks. Key characteristics of the system include: * Non-implantable * Externally applied * No electrical stimulation delivered to the body * No invasive components or procedures * No life-sustaining or life-supporting function The device consists of a handheld, battery-powered controller, an eyeset, and a power charger. The device is intended for daily use at home.