Axial Length With Adult Onset Myopia (ALWAOM)

NCT ID: NCT05559567

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-08-31

Brief Summary

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

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.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Orthokeratology

Intervention Type: DEVICE

The use of a specialty GP contact lens to temporarily correct myopia

Interventions

Orthokeratology

The use of a specialty GP contact lens to temporarily correct myopia

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri, St. Louis

OTHER

Sponsor Role: collaborator

Art Optical Contact Lens, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Missouri-St. Louis College of Optometry

St Louis, Missouri, United States

Countries

United States

Other Identifiers

ALWAOM2022

Identifier Type: -

Identifier Source: org_study_id