Axial Length With Adult Onset Myopia (ALWAOM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Orthokeratology.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 21 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Axial Length With Adult Onset Myopia
Overview
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
- Device Orthokeratology
The use of a specialty GP contact lens to temporarily correct myopia
Primary outcome measures
- Axial Length progression [Time frame: Two years]
- Effect of Orthokeratology on axial length changes [Time frame: Two years]
Eligibility criteria
Inclusion criteria
- 1st year optometry student
- Refractive error - spherical Component: +2.00D to -5.00D; astigmatic Component: up to -1.50D; non-presbyopic
- Not currently using any treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control
- No significant anterior or posterior segment disease
Exclusion criteria
- Non-graduate student
- Refractive error outside of: +2.00D to -5.00D; astigmatic Component: up to -1.50D; presbyopic
- Any participants using treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control
- Significant anterior or posterior segment disease
- Pregnancy
- Significant systemic disease that may affect refractive error (i.e. diabetes)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Missouri-St. Louis College of Optometry — St Louis
Identifiers
NCT: NCT05559567 · ALWAOM2022