Kubota Glass Parameter Refinement Study

NCT06085430 | Completed FDA Device

• 1 other identifier: KV-JAX-RCT-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Myopia, Progressive; Vision Disorders

Keywords

myopia; spectacles

Outcome Measures

Primary Outcomes (1)

• Axial length

  Change in axial length as measured by optical biometry after the use of Kubota Glass

  2 hours

Study Arms (2)

Right eyes: Treatment

EXPERIMENTAL

Device: Kubota Glass

Left eyes: Control

NO INTERVENTION

Interventions

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.

Right eyes: Treatment

Eligibility Criteria

• Age: 8 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kubota Vision Inc.: lead

Study Sites (1)

InOptix Eyecare Center

Jacksonville, Florida, 32256, United States

Location

MeSH Terms

Conditions

Myopia; Myopia, Degenerative; Vision Disorders

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: November 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

US (1)