Kubota Glass Parameter Refinement Study

Sponsor

Kubota Vision Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06085430

Collaborator

(none)

Enrollment

Arms

6.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia Myopia, Progressive Vision Disorders	Device: Kubota Glass	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effects of Various Stimulus Characteristics on Myopic Progression Using Kubota Glass

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

May 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Right eyes: Treatment	Device: Kubota Glass 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.
No Intervention: Left eyes: Control

Arm

Intervention/Treatment

Experimental: Right eyes: Treatment

Device: Kubota Glass

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.

No Intervention: Left eyes: Control

Outcome Measures

Primary Outcome Measures

Axial length [2 hours]
Change in axial length as measured by optical biometry after the use of Kubota Glass

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kubota Vision Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kubota Vision Inc.

ClinicalTrials.gov Identifier:

NCT06085430

Other Study ID Numbers:

KV-JAX-RCT-001

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Kubota Vision Inc.

myopia

spectacles

Additional relevant MeSH terms:

Vision Disorders

Myopia

Myopia, Degenerative

Study Results

No Results Posted as of Oct 17, 2023