NCT05559567

Axial Length With Adult Onset Myopia (ALWAOM)

Axial Length With Adult Onset Myopia

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Art Optical Contact Lens, Inc. · Industry
• Sex: All
• Age: 21 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Orthokeratology	The use of a specialty GP contact lens to temporarily correct myopia

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-05-01
• Completion: 2025-08-01
• First posted: 2022-09-29
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study