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Axial Length With Adult Onset Myopia (ALWAOM) (ALWAOM)

Primary Purpose

Myopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orthokeratology
Sponsored by
Art Optical Contact Lens, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myopia focused on measuring Axial Length, Myopia

Eligibility Criteria

21 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 1st year optometry student
  2. Refractive error - spherical Component: +2.00D to -5.00D; astigmatic Component: up to -1.50D; non-presbyopic
  3. Not currently using any treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control
  4. No significant anterior or posterior segment disease

Exclusion Criteria:

  1. Non-graduate student
  2. Refractive error outside of: +2.00D to -5.00D; astigmatic Component: up to -1.50D; presbyopic
  3. Any participants using treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control
  4. Significant anterior or posterior segment disease
  5. Pregnancy
  6. Significant systemic disease that may affect refractive error (i.e. diabetes)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Orthokeratology

    Arm Description

    Orthokeratology is fitting of a contact lens for overnight wear to flatten the cornea and correct myopia temporarily during the day. This procedure has also been shown to slow down the axial length growth in children.

    Outcomes

    Primary Outcome Measures

    Axial Length progression
    The change in the length of the eye from the anterior cornea to the retina over time
    Effect of Orthokeratology on axial length changes
    Compare the average axial length changes of subjects wearing orthokeratology lenses to those who do not

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2022
    Last Updated
    September 26, 2022
    Sponsor
    Art Optical Contact Lens, Inc.
    Collaborators
    University of Missouri, St. Louis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05559567
    Brief Title
    Axial Length With Adult Onset Myopia (ALWAOM)
    Acronym
    ALWAOM
    Official Title
    Axial Length With Adult Onset Myopia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    May 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Art Optical Contact Lens, Inc.
    Collaborators
    University of Missouri, St. Louis

    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
    No

    5. Study Description

    Brief Summary
    Purpose: To determine axial length progression and its relationship with myopia onset and progression in adults.
    Detailed Description
    Objectives Determine axial length progression over a two year period of at least 100 subjects/students aged 21 or over (subjects may come from multiple sites). Subjects are to be chosen from optometric education programs beginning in the student's first year. Determine correlation of axial length changes to refractive changes over the two year period. Obtain results of orthokeratology and its effect on axial length and refractive changes. Methods Measurements of axial length with optical biometry will be taken at yearly intervals for three years and recorded on a spreadsheet (see attached) for future data analysis. Effort will be made to perform measurements at approximately same date each year. Refractive error will be measured using a consistent method such as an autorefractor at yearly intervals for three years and recorded on same spreadsheet as axial length for future data analysis. Effort will be made to perform measurements at approximately same date each year. Subjects that are fit into orthokeratology will be fit with the MOONLENS design (provided by Art Optical at no charge) per normal fitting protocol and followed up with normal protocol Axial length will be measured pre-fitting and at least every year for the three year period. Topography will be captured at pre-fitting and post fitting per normal protocol with images taken at least once per year for three year period. Refraction will also be conducted at least once per year. Axial length and refraction data are to be recorded on same spreadsheet as above and topography saved to a separate folder for future analysis.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Orthokeratology
    Arm Type
    Other
    Arm Description
    Orthokeratology is fitting of a contact lens for overnight wear to flatten the cornea and correct myopia temporarily during the day. This procedure has also been shown to slow down the axial length growth in children.
    Intervention Type
    Device
    Intervention Name(s)
    Orthokeratology
    Intervention Description
    The use of a specialty GP contact lens to temporarily correct myopia
    Primary Outcome Measure Information:
    Title
    Axial Length progression
    Description
    The change in the length of the eye from the anterior cornea to the retina over time
    Time Frame
    Two years
    Title
    Effect of Orthokeratology on axial length changes
    Description
    Compare the average axial length changes of subjects wearing orthokeratology lenses to those who do not
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1st year optometry student Refractive error - spherical Component: +2.00D to -5.00D; astigmatic Component: up to -1.50D; non-presbyopic Not currently using any treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control No significant anterior or posterior segment disease Exclusion Criteria: Non-graduate student Refractive error outside of: +2.00D to -5.00D; astigmatic Component: up to -1.50D; presbyopic Any participants using treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control Significant anterior or posterior segment disease Pregnancy Significant systemic disease that may affect refractive error (i.e. diabetes)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bruce W Morgan
    Phone
    616-559-5182
    Email
    bmorgan@artoptical.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Axial Length With Adult Onset Myopia (ALWAOM)

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