Axial Length With Adult Onset Myopia (ALWAOM)

Sponsor
Art Optical Contact Lens, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05559567
Collaborator
University of Missouri, St. Louis (Other)
100
1
35

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Orthokeratology
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Axial Length With Adult Onset Myopia
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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
The use of a specialty GP contact lens to temporarily correct myopia

Outcome Measures

Primary Outcome Measures

  1. Axial Length progression [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 [Two years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 35 Years
Sexes Eligible for Study:
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:
  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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Art Optical Contact Lens, Inc.
  • University of Missouri, St. Louis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Art Optical Contact Lens, Inc.
ClinicalTrials.gov Identifier:
NCT05559567
Other Study ID Numbers:
  • ALWAOM2022
First Posted:
Sep 29, 2022
Last Update Posted:
Sep 29, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Art Optical Contact Lens, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2022