NCT05559567

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

September 26, 2022

Last Update Submit

August 5, 2024

Conditions

Keywords

Axial LengthMyopia

Outcome Measures

Primary Outcomes (2)

  • Axial Length progression

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

    Two years

  • Effect of Orthokeratology on axial length changes

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

    Two years

Study Arms (1)

Orthokeratology

OTHER

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

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

Orthokeratology

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • st 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-St. Louis College of Optometry

St Louis, Missouri, 63121, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 29, 2022

Study Start

September 1, 2023

Primary Completion

May 1, 2025

Study Completion

August 1, 2025

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations