Clinical trial NCT05559567: Axial Length With Adult Onset Myopia (ALWAOM)
Official title: Axial Length With Adult Onset Myopia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Myopia
Keywords: Axial Length
Myopia
Lead sponsor: Art Optical Contact Lens, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Missouri, St. Louis
First posted: 2022-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Axial Length progression
timeFrame: Two years
measure: Effect of Orthokeratology on axial length changes
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: University of Missouri-St. Louis College of Optometry
state: Missouri
Study officials:
References: