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Orthokeratology

Orthokeratology for Near-sightedness (ALWAOM Trial)

N/A

Waitlist Available

Research Sponsored by Art Optical Contact Lens, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to understand how the length of the eye changes over time and how it is related to the development and worsening of nearsightedness in adults."

Who is the study for?

This trial is for first-year optometry students with mild to moderate near-sightedness (+2.00D to -5.00D) and astigmatism up to -1.50D, who are not presbyopic, have never used myopia control treatments like Orthokeratology lenses or specific drugs, and do not have significant eye diseases.

What is being tested?

The study aims to understand how the length of the eye changes in adults developing near-sightedness by using a non-surgical treatment called Orthokeratology, which reshapes the cornea temporarily using special contact lenses worn overnight.

What are the potential side effects?

Orthokeratology may cause temporary side effects such as mild discomfort or vision disturbances when you start wearing the lenses. There's also a small risk of infection from improper lens care or handling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not using any treatments to control nearsightedness.

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My eyes do not have any major diseases.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am using treatments to control my nearsightedness.

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I have a serious eye condition affecting the front or back part of my eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Axial Length progression

Effect of Orthokeratology on axial length changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: OrthokeratologyExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Orthokeratology

2016

Completed Phase 4

~290

0 / 4Eligibility criteria met