Kubota Glass Parameter Refinement Study | NCT06085430

Studies
Kubota Glass Parameter Refinement Study

NCT06085430

Sponsor

Kubota Vision Inc.

Status

Completed

Last Update Posted

Dec 12, 2024Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Myopia
Myopia, Progressive
Vision Disorders

Interventions

Kubota Glass

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Sep 30, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

Oct 10, 2023

First Submission Date that Met QC Criteria

Oct 10, 2023

First Posted Date

Oct 17, 2023Actual

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

Dec 8, 2024

Last Update Posted Date

Dec 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Length of the eye will be measured in subjects exposed to various stimulus characteristics using an electronic spectacle which presents illuminated targets to the eye. The results will be analyzed to determine which stimulus characteristics may be most beneficial for use in the device.

Detailed Description

Axial length measurements will be taken before and after two-hour monocular exposure to various stimulus characteristics using an electronic spectacle which presents illuminated defocus targets to the retina. Areas of investigation include the dioptric amount of defocus, the intensity of illumination, the spectrum of illumination, and the shape of the illumination target. The transient axial length results will be analyzed to determine which stimulus characteristics may be most beneficial for slowing myopic eye growth.

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Right eyes: Treatment	Experimental		Device: Kubota Glass
Left eyes: Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kubota Glass	Device	Kubota Glass employs white light producing micro-LEDs covered by masks which create a patterned target. The patterned images are defocused by micro-lenslets and projected to the retinal periphery by a central mirror. Parameters of interest to evaluate in this investigation include but are not limited to dioptric amount of defocus, brightness (cd/m2), spectrum of illumination, and shape of the target mask. In each scenario, right eyes will be exposed to the stimulus, whereas left eyes serve as controls. The order of exposures to the various stimuli will be randomized to participant and investigator.

Measure	Description	Time Frame
Axial length	Change in axial length as measured by optical biometry after the use of Kubota Glass	2 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
Sign written Informed Consent (and the California Bill of Rights, if applicable).
Ages 8-24 (inclusive) and able to understand and assent to participation
Have need of optical correction for myopia, from -1.00 to -5.00 diopters (D).
Have a refractive astigmatism of less than -1.00 D.
Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better.
Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion Criteria:

Not able or willing to provide informed consent and assent
Eye injury or surgery within twelve weeks immediately prior to enrollment
Currently enrolled in an ophthalmic clinical trial
Pregnant or lactating or expect to become pregnant during the trial
Evidence of systemic or ocular abnormality, infection or disease
Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye
Habitually uncorrected anisometropia ≥ 2.00
Subjects who have undergone corneal refractive surgery
Use of a treatment for myopia progression within the past 6 months, including atropine, specialized spectacle lenses, orthokeratology, specialized soft contact lenses

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

24 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
InOptix Eyecare Center		Jacksonville	Florida	32256	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Upon reasonable request with a plan approved for what the data will be used for, data sharing might be considered

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009216	Myopia
D047728	Myopia, Degenerative
D014786	Vision Disorders

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases
D012678	Sensation Disorders
D009461	Neurologic Manifestations