Kubota Glass Parameter Refinement Study

Effects of Various Stimulus Characteristics on Myopic Progression Using Kubota Glass

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia; Vision Disorders; Myopia, Progressive
• Intervention / Treatment: Device: Kubota Glass

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kubota Vision Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: spectacles; myopia
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Myopia; Vision Disorders; Myopia, Degenerative
• Other Study ID Numbers: KV-JAX-RCT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No