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Axial Length With Adult Onset Myopia (ALWAOM)

Axial Length With Adult Onset Myopia

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05559567
Acronym
ALWAOM
Enrollment
100
Registered
2022-09-29
Start date
2023-09-01
Completion date
2025-08-31
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Axial Length, Myopia

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.

Interventions

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

Sponsors

University of Missouri, St. Louis
CollaboratorOTHER
Art Optical Contact Lens, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Axial Length progressionTwo yearsThe change in the length of the eye from the anterior cornea to the retina over time
Effect of Orthokeratology on axial length changesTwo yearsCompare the average axial length changes of subjects wearing orthokeratology lenses to those who do not

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026