Binocular Peripheral Myopic Defocus Using a Clinical Prot... | NCT05425108

Studies
Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

NCT05425108

Sponsor

Kubota Vision Inc.

Status

Unknown status

Last Update Posted

Jul 6, 2022Actual

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Myopia

Interventions

Binocular CP1

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 23, 2022Actual

Primary Completion Date

Aug 2023Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Jun 15, 2022

First Submission Date that Met QC Criteria

Jun 15, 2022

First Posted Date

Jun 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2022

Last Update Posted Date

Jul 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CP1 device	Active Comparator		Device: Binocular CP1
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Binocular CP1	Device	Binocular active projection of defocused image in the peripheral visual field	CP1 device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Central axial length		12 months
Cycloplegic refraction		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Helpdesk	Contact	(206) 805-8310		ClinicalTrails@kubotavision.com

Overall Officials

Name	Affiliation	Role
Arkady Selenow, OD	Manhattan Vision Associates/Institute of Vision Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manhattan Vision Associates/Institute of Vision Research	Recruiting	New York	New York	10022	United States

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided