CURESIGHT BINOCULAR AMBLYOPIA TREATMENT STUDY

Summary

Screening A child is considered for the study after undergoing a standard of care and study specific eye examinations (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent(s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent / assent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care.

On screening visit, eligibility assessment, medical history,Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing , Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing-Randot, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional)

Randomization The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform.

All eligible subjects enrolled in the study will be followed for 16 weeks. Subjects will be randomly assigned in a 1:1 allocation to one of the following treatment groups for 16 weeks:

1. Binocular treatment 90 minutes per day, 5 days per week
2. Patching group: Patching 2 hours per day, 7 days per week.

Follow up visits

* 1-week phone call (4 to 8 days from randomization) to inquire about issues with the CureSight system (if applicable) and to encourage compliance with treatment for all groups (to be completed by site personnel)
* Visit 2: 4 weeks ± 1 week
* Visit 3: 8 weeks ± 1 week
* Visit 4: 12 weeks ± 1 week
* Visit 5: 16 weeks ± 1 week (primary endpoint)
* Unmasking of primary outcome results
* For each individual subject, clinician's decision regarding:

Treatment or control cessation and follow-up; or, Control (patching) continuation with same modality (more improvement desired); or, Cross-over to a different treatment (avoid missing the optimal window of opportunity in young age)

•Optional Visit 6: 28 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes

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.

Sponsors & Collaborators

• NovaSight

  lead INDUSTRY

Principal Investigators

• Eric Crouch, MD · Virginia Pediatric Eye Center 4665 South Blvd. Virginia Beach, VA 23452

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-31

Primary Completion

2023-05-01

Completion

2023-05-01

FDA Device

Yes

Countries

• United States

Study Locations