NCT05425108

Brief Summary

Kubota Vision Inc. has developed a spectacle-like prototype device which is designed to be used as a light-based therapy to reduce myopia progression. In this study, we aim to observe the ocular biometric and refractive changes following binocular part-time wear of the clinical prototype device over a course of 12 months and compare that to 12 months of no clinical prototype device use (control).

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

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

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

June 23, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

June 15, 2022

Last Update Submit

June 30, 2022

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Central axial length

    12 months

  • Cycloplegic refraction

    12 months

Study Arms (2)

CP1 device

ACTIVE COMPARATOR
Device: Binocular CP1

Control

NO INTERVENTION

Interventions

Binocular CP1DEVICE

Binocular active projection of defocused image in the peripheral visual field

CP1 device

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spherical equivalent -0.50 to -5.50 diopters
  • visual acuity of at least 20/25 in each eye

You may not qualify if:

  • history of ocular trauma or major eye surgery
  • active ocular infection
  • any prior history or participation in myopia control treatments within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Vision Associates/Institute of Vision Research

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Arkady Selenow, OD

    Manhattan Vision Associates/Institute of Vision Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Helpdesk

CONTACT

(206) 805-8310ClinicalTrails@kubotavision.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

June 23, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

July 6, 2022

Record last verified: 2022-06

Locations

US(1)