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Enrolling by Invitation

NCT Number: NCT05559567

Axial Length With Adult Onset Myopia (ALWAOM)

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

Enrolling by Invitation

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Key information

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-St. Louis College of Optometry

St Louis, Missouri, 63121, United States

About this study

Objectives

  • 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.
  • Determine correlation of axial length changes to refractive changes over the two year period.
  • Obtain results of orthokeratology and its effect on axial length and refractive changes.

Methods

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Orthokeratology

Device

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

Primary outcomes

  1. Axial Length progression

    Time frame: Two years

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

  2. Effect of Orthokeratology on axial length changes

    Time frame: Two years

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

Sponsors and collaborators

Lead sponsor

Art Optical Contact Lens, Inc.

Industry

Collaborators

  • University of Missouri, St. Louis

Registry information

Official study title

Axial Length With Adult Onset Myopia

Acronym: ALWAOM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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