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Eye-tracking Based Amblyopia Training

NCT05078099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-08-08

No results posted yet for this study

Summary

An Eye-Tracking-Based Binocular Amblyopia Technology Improves Both Visual Acuity and Binocularity

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 the standard of care) that identify 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 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- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional).

All eligible subjects enrolled in the study will be followed for 24 weeks of training followed by 52 weeks of follow-up.

24 weeks: Binocular treatment 90 minutes per day, 5 days per week for 12 weeks followed by 90 minutes per day, 3 days per week for an additional 12 weeks

Follow up visits

* Visit 1: 4 weeks ± 1 week
* Visit 2: 8 weeks ± 1 week
* Visit 3: 12 weeks ± 1 week
* Visit 4: 24 weeks ± 1 week (primary endpoint)
* Optional Visit 5: 52 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes)

Conditions

  • Amblyopia

Interventions

DEVICE

CureSight

Binocular eye-tracking-based passive home treatment system delivering personalized amblyopia therapy

Sponsors & Collaborators

  • NovaSight

    lead INDUSTRY

Principal Investigators

  • Tamara Wygnanski-Jaffe, MD · Sheba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2020-03-19
Completion
2020-03-19

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078099 on ClinicalTrials.gov