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Electronic Spectacles Versus Low Dose Atropine in Young Myopes

Primary Purpose

Myopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eSpectacle Clinical prototype (CP1) device
0.01% atropine
Sponsored by
Kubota Vision Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

6 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The subject must be between 6 and 13 years of age (inclusive). The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol. The guardian of a minor under 18 years old must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject under 18 years old must be willing to assent to the STATEMENT OF INFORMED CONSENT. Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye. Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format). Best corrected distance VA of at least 20/25 in each eye. Exclusion Criteria: Currently pregnant or lactating History of severe dry eye, strabismus, or amblyopia Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., diabetes, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with the participation in the study at the investigator's discretion. Use of systemic or ocular medications (e.g., chronic steroid use) that are known to interfere with vision and ocular accommodation at the investigator's discretion. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology Any active ocular infection. Any accommodative or binocular anomalies including amblyopia. Any physical or mental developmental delay. Any relevant ocular or systemic condition deemed unacceptable by the investigator that may negatively impact the subject's performance or ability to successfully complete the study (at the investigator's discretion) Anisometropia greater than 1.50D

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Clinical prototype (CP1) device

    CP1 and 0.01% atropine

    0.01% atropine

    Arm Description

    15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week. Standard single vision correction will be used during other waking hours. The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina.

    15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week, in addition to nightly instillation of one drop of 0.01% atropine. Standard single vision correction will be used during other waking hours. The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia.

    15 subjects will be randomly assigned to nightly instillation of one drop of 0.01% atropine without use of the eSpectacle clinical prototype (CP1) device. Standard single vision correction will be used during waking hours. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia.

    Outcomes

    Primary Outcome Measures

    CSER
    Difference in the changes of cycloplegic spherical refractive error between each of the three treatment groups.
    AL
    Difference in the changes of axial length between each of the three treatment groups.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2023
    Last Updated
    September 18, 2023
    Sponsor
    Kubota Vision Inc.
    Collaborators
    China Medical University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06034379
    Brief Title
    Electronic Spectacles Versus Low Dose Atropine in Young Myopes
    Official Title
    Kubota Corrective Spectacles and Low Dose Atropine for Slowing Myopic Progression in Taiwanese Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kubota Vision Inc.
    Collaborators
    China Medical University Hospital

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a bilateral, dispensing, masked, randomized clinical trial. Myopic children will be randomly assigned to one of the following: (1) Investigational clinical prototype (CP1) device without atropine, (2) Investigational CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01% atropine without use of the investigational CP1 device. Primary endpoint: Difference in the 12-month change of cycloplegic spherical refractive error and axial length between each of the three treatment groups.
    Detailed Description
    The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. In this pilot investigation, we aim to observe the ocular biometric and refractive changes following part-time wear of the clinical prototype device over a course of 12 months. This trial is bilateral, dispensing, masked, and randomized (stratified by age). Myopic children will be randomly assigned to one of the following: (1) CP1 device without atropine, (2) CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01% atropine without use of the CP1 device. A total of 45 subjects (15 per subgroup) are targeted to complete the study, which will consist of 8 visits: Screening, baseline/dispense, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months. Subjects will be enrolled from the patient population at the investigator site. The primary objective is to evaluate the effectiveness of the eSpectacle clinical prototype device with and without the use of 0.01 percent atropine for slowing the progression of myopia in Taiwanese children, by assessing changes in central axial length and cycloplegic autorefraction following at least 12 hours per week of wear over 12 months. To minimize bias, the primary outcome variables of cycloplegic autorefraction and axial length will be measured by a Masked Investigator.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinical prototype (CP1) device
    Arm Type
    Experimental
    Arm Description
    15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week. Standard single vision correction will be used during other waking hours. The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina.
    Arm Title
    CP1 and 0.01% atropine
    Arm Type
    Experimental
    Arm Description
    15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week, in addition to nightly instillation of one drop of 0.01% atropine. Standard single vision correction will be used during other waking hours. The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia.
    Arm Title
    0.01% atropine
    Arm Type
    Experimental
    Arm Description
    15 subjects will be randomly assigned to nightly instillation of one drop of 0.01% atropine without use of the eSpectacle clinical prototype (CP1) device. Standard single vision correction will be used during waking hours. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia.
    Intervention Type
    Device
    Intervention Name(s)
    eSpectacle Clinical prototype (CP1) device
    Intervention Description
    The CP1 device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights of approximately 4800 nits illumination to the peripheral retina.
    Intervention Type
    Drug
    Intervention Name(s)
    0.01% atropine
    Intervention Description
    Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.
    Primary Outcome Measure Information:
    Title
    CSER
    Description
    Difference in the changes of cycloplegic spherical refractive error between each of the three treatment groups.
    Time Frame
    12 months
    Title
    AL
    Description
    Difference in the changes of axial length between each of the three treatment groups.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The subject must be between 6 and 13 years of age (inclusive). The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol. The guardian of a minor under 18 years old must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject under 18 years old must be willing to assent to the STATEMENT OF INFORMED CONSENT. Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye. Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format). Best corrected distance VA of at least 20/25 in each eye. Exclusion Criteria: Currently pregnant or lactating History of severe dry eye, strabismus, or amblyopia Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., diabetes, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with the participation in the study at the investigator's discretion. Use of systemic or ocular medications (e.g., chronic steroid use) that are known to interfere with vision and ocular accommodation at the investigator's discretion. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology Any active ocular infection. Any accommodative or binocular anomalies including amblyopia. Any physical or mental developmental delay. Any relevant ocular or systemic condition deemed unacceptable by the investigator that may negatively impact the subject's performance or ability to successfully complete the study (at the investigator's discretion) Anisometropia greater than 1.50D

    12. IPD Sharing Statement

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    Electronic Spectacles Versus Low Dose Atropine in Young Myopes

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