CClinicalTrials.gg
Sign In
Enrolling by invitationNCT05559567ALWAOMUpdated Aug 6, 2024

Axial Length With Adult Onset Myopia (ALWAOM)

An interventional study of Orthokeratology in Myopia, sponsored by Art Optical Contact Lens, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 21 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Art Optical Contact Lens, Inc. · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
21 Years to 35 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Myopia

Browse trials for

Keywords

  • Axial Length
  • Myopia
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

This is the only study on the registry with Art Optical Contact Lens, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 35 Years
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    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.

    Device: Orthokeratology

Interventions

  • DeviceOrthokeratology

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

06

What researchers measure

Primary outcomes

  1. Axial Length progression

    The change in the length of the eye from the anterior cornea to the retina over time

    Time frame: Two years

  2. Effect of Orthokeratology on axial length changes

    Compare the average axial length changes of subjects wearing orthokeratology lenses to those who do not

    Time frame: Two years

07

Study locations

1 site
  • University of Missouri-St. Louis College of Optometry
    Saint Louis, Missouri 63121, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05559567
Lead sponsor
Art Optical Contact Lens, Inc.
Collaborators
University of Missouri, St. Louis
Responsible party
Sponsor
First posted
Sep 29, 2022
Start date
Sep 1, 2023
Primary completion
May 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Aug 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Myopia→

Start the discussion