Kubota Glass Parameter Refinement Study

NCT ID: NCT06085430

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-09-30

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.

Conditions

Myopia; Myopia, Progressive; Vision Disorders

Keywords

myopia; spectacles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Right eyes: Treatment

Group Type: EXPERIMENTAL

Kubota Glass

Intervention Type: 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.

Left eyes: Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kubota Vision Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

InOptix Eyecare Center

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

KV-JAX-RCT-001

Identifier Type: -

Identifier Source: org_study_id