NCT06165705

Brief Summary

Patients with visual acuity and ocular characteristics outside the Novasight FDA multi-center study are to perform the same Curesight procedures- including M\&S EVA or eETDRS patched acuity, stereo and then utilize the Curesight device 1.5 hours per day, 6 days per week over 3-6 months to determine treatment efficacy. An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial T. Wygnanski-Jaffe, B. J. Kushner, A. Moshkovitz, M. Belkin, O. Yehezkel and G. CureSight Pivotal Trial Ophthalmology 2023 Vol. 130 Issue 3 Pages 274-285

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 26, 2024

Status Verified

January 1, 2024

Enrollment Period

2.8 years

First QC Date

December 4, 2023

Last Update Submit

August 23, 2024

Conditions

Amblyopia

Keywords

refractive amblyopia, strabismic amblyopia, anisometropia

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Amblyopic eye best corrected visual acuity

    2-6 months

Secondary Outcomes (1)

  • stereopsis

    2-6 months

Study Arms (1)

Amblyopia therapy with Curesight outside FDA limited ranges

EXPERIMENTAL

Severity of amblyopia and age range outside FDA study

Device: CureSight

Interventions

CureSightDEVICE

dichoptic therapy with anaglyph goggles and eye tracking

Also known as: dichoptic therapy with anaglyph goggles and eye tracking
Amblyopia therapy with Curesight outside FDA limited ranges

Eligibility Criteria

Age2 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • amblyopia

You may not qualify if:

  • lack of brain and eye capacity for improved vision lack of home WiFi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Blind Child Discovery

Anchorage, Alaska, 99508, United States

RECRUITING

Related Publications (2)

  • Wygnanski-Jaffe T, Kushner BJ, Moshkovitz A, Belkin M, Yehezkel O; CureSight Pivotal Trial Group. An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial. Ophthalmology. 2023 Mar;130(3):274-285. doi: 10.1016/j.ophtha.2022.10.020. Epub 2022 Oct 26.

    PMID: 36306974RESULT

  • Arnold RW. Dichoptic Rescue for Spectacle-Flip Sabotage of Anisometropic Amblyopia Therapy. Clin Optom (Auckl). 2024 Mar 5;16:83-87. doi: 10.2147/OPTO.S454342. eCollection 2024.

    PMID: 38476961DERIVED

MeSH Terms

Conditions

AmblyopiaAnisometropia

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRefractive Errors

Intervention Hierarchy (Ancestors)

Eye Movement MeasurementsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Robert W Arnold, MD

    Alaska Blind Child Discovery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert W Arnold, MD

CONTACT

9075611917eyedoc@alaska.net

Jennifer Plachinski

CONTACT

9075611917jplachinski@alaskachildrenseye.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: treatment efficacy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 11, 2023

Study Start

March 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)