Eye-tracking Based Amblyopia Training

NCT05078099 | Completed DMC

• 1 other identifier: NS-00101-R01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Amblyopia; Lazy eye; Binocular treatment; Dichoptic treatment; Eye tracking; Visual acuity; Stereoacuity; Adherence

Outcome Measures

Primary Outcomes (2)

• Best-Corrected Visual Acuity of Amblyopic Eye

  Mean visual acuity change from baseline Using LogMAR LEA symbols optotype for participants \< 7 years of age and LEA numbers optotype for participants ≥ 7 years of age

  24 weeks

• Best-Corrected Visual Acuity of Fellow Eye

  Mean visual acuity change from baseline Using LogMAR LEA symbols for participants \< 7 years of age and LEA numbers for participants ≥ 7 years of age

  24 weeks

Secondary Outcomes (3)

• Adherence

  4, 8, 12, and 24 weeks

• Stereoacuity

  4, 8, 12, and 24 weeks

• Amblyopic eye best-corrected visual acuity

  4, 8, 12, and 24 weeks

Study Arms (1)

Study arm - Binocular CureSight

EXPERIMENTAL

Using binocular treatment device 90 min a day 5 times a week for 12 weeks following by 90 min a day 3 times a week for additional 12 weeks

Device: CureSight

Interventions

CureSight DEVICE

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

Study arm - Binocular CureSight

Eligibility Criteria

• Age: 4 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The following criteria must be met for a child to be enrolled in the study:
• Age 4 to 40 years male and female
• Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
• Must have refractive error correction (based on a cycloplegic refraction completed within the last 7 months)
• Spectacle correction meeting the above criteria must be worn For at least 16 weeks OR until distance VA stability is documented (defined as \<0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
• VA, measured in each eye without cycloplegia in current spectacle correction using the Lea symbol per ATS VA protocol for children \< 7 years and the EETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:
• Visual acuity in the amblyopic eye \<1.0 logMAR (20/200)
• Best-corrected dominant-eye VA \<0.2
• Interocular difference ≥ 2 logMAR lines
• Heterotropia with a near deviation of \<5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation \>4∆ are not allowed because large magnitudes of the deviation would compromise successful alignment of the dichoptic stimuli.)
• Passing a dedicated 10 min in-clinic performance ability test to assure suitable eye tracking performance (validity of eye tracking data \>90% and successful calibration process).
• \. Subjects and families eligible for clinic visits over duration of study.
• \. Subject in general good health and able, as per investigator decision, to comply with study visits and protocol procedures and wear refractive correction and has access to wireless internet at home which is able to support the CureSight treatment (loaned by sponsor).
• \. Signed and dated informed consent form.
• \. Parent and participant understand and are willing to comply with study procedures and will be available for the duration of the study.

You may not qualify if:

• Myopia greater than -6.00 D. spherical equivalent in either eye.
• Known skin reactions to patch or bandage adhesives.
• Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator).
• Any condition that might interfere with eye tracking, such as ptosis
• Any reported anatomic ocular anomaly (e.g., small lens opacity, myelinated nerve fiber layer).
• Previous intraocular or refractive surgery.
• Heterophoria with a total near deviation of ≥10Δ (measured by PACT

Sponsors & Collaborators

• NovaSight: lead

Study Sites (1)

Sheba medical center

Ramat Gan, Select A State, 52621, Israel

Location

Related Links

• Related Info

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tamara Wygnanski-Jaffe, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm prospective

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 14, 2021
• Study Start: December 5, 2018
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: August 8, 2023

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)