Axial Length With Adult Onset Myopia (ALWAOM)

Myopia Clinical Trial

— ALWAOM  

Official title:

Axial Length With Adult Onset Myopia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05559567
• Other study ID #: ALWAOM2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: August 2025

Study information

• Verified date: September 2022
• Source: Art Optical Contact Lens, Inc.
• Contact: Bruce W Morgan
• Phone: 616-559-5182
• Email: bmorgan[@]artoptical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Orthokeratology
The use of a specialty GP contact lens to temporarily correct myopia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Art Optical Contact Lens, Inc.	University of Missouri, St. Louis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial Length progression	The change in the length of the eye from the anterior cornea to the retina over time	Two years
Primary	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