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
About this trial
This is an interventional diagnostic trial for Myopia focused on measuring Axial Length, Myopia
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)
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
NCT ID
NCT05559567
First Posted
September 26, 2022
Last Updated
September 26, 2022
Sponsor
Art Optical Contact Lens, Inc.
Collaborators
University of Missouri, St. Louis
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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