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Kubota Glass Parameter Refinement Study

Primary Purpose

Myopia, Myopia, Progressive, Vision Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kubota Glass
Sponsored by
Kubota Vision Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia, spectacles

Eligibility Criteria

8 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Right eyes: Treatment

    Left eyes: Control

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2023
    Last Updated
    October 10, 2023
    Sponsor
    Kubota Vision Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06085430
    Brief Title
    Kubota Glass Parameter Refinement Study
    Official Title
    Effects of Various Stimulus Characteristics on Myopic Progression Using Kubota Glass
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    May 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kubota Vision Inc.

    4. Oversight

    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

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Myopia, Progressive, Vision Disorders
    Keywords
    myopia, spectacles

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Right eyes: Treatment
    Arm Type
    Experimental
    Arm Title
    Left eyes: Control
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Kubota Glass
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Axial length
    Description
    Change in axial length as measured by optical biometry after the use of Kubota Glass
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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