CURESIGHT BINOCULAR AMBLYOPIA TREATMENT STUDY

NACompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

March 31, 2021

Primary Completion Date

May 1, 2023

Study Completion Date

May 1, 2023

Conditions
Amblyopia
Interventions
DEVICE

CureSight

Subjects assigned to the binocular treatment group will be prescribed the CureSight treatment to watch for 90 minutes per day, 5 days a week for 16 weeks for the total of 120 hours. Parents of subjects will be instructed that the 90 minutes of daily treatment should be completed in a single 90-minute session, but if this is not possible for whatever reason, the treatment may be divided into two shorter sessions totaling 90 minutes per day

DEVICE

Patching

"Subjects assigned to the patching group will wear an adhesive patch over the dominant eye for 2 hours per day, 7 days per week for 16 weeks. Parents of subjects will be instructed that the 2 hours of daily patching should be completed in a single 2-hour session, but if this is not possible for whatever reason, the treatment may be divided into shorter sessions totaling 2 hours.~Parents will be asked to complete a usage diary by manually recording the patch usage time on daily basis."

Trial Locations (1)

23452

Virginia Pediatric Eye Center, Virginia Beach

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NovaSight

INDUSTRY

NCT04785690 - CURESIGHT BINOCULAR AMBLYOPIA TREATMENT STUDY | Biotech Hunter | Biotech Hunter