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

Axial Length With Adult Onset Myopia

Purpose: To determine axial length progression and its relationship with myopia onset and progression in adults.

Study Overview

• Status: Enrolling by invitation
• Conditions: Myopia
• Intervention / Treatment: Device: Orthokeratology

Detailed Description

Objectives

1. 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.
2. Determine correlation of axial length changes to refractive changes over the two year period.
3. Obtain results of orthokeratology and its effect on axial length and refractive changes.

Methods

1. 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.
2. 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.
3. 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63121
      • University of Missouri-St. Louis College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Orthokeratology; 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.	Device: Orthokeratology; The use of a specialty GP contact lens to temporarily correct myopia

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Art Optical Contact Lens, Inc.
• Collaborators: University of Missouri, St. Louis

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Myopia; Axial Length
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: ALWAOM2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No