Orthokeratology for Near-sightedness
(ALWAOM Trial)

Overseen ByBruce W Morgan

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Art Optical Contact Lens, Inc.

Must not be taking: Myopia control treatments

Disqualifiers: Non-graduate, Pregnancy, Diabetes, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

If you are currently using any treatment for myopia control, such as Orthokeratology lenses, soft multifocal lenses, MiSight lenses, or any related medications, you will need to stop using them to participate in this trial.

What data supports the effectiveness of the treatment Orthokeratology for Near-sightedness?

Research shows that orthokeratology is effective in slowing the progression of myopia (nearsightedness) in children and young people, as well as correcting myopia in general.¹ ² ³ ⁴ ⁵

How does the treatment Orthokeratology differ from other treatments for near-sightedness?

Orthokeratology is unique because it uses specially designed contact lenses worn overnight to temporarily reshape the cornea, reducing near-sightedness without surgery or daytime lenses. This method is different from traditional glasses or daytime contact lenses, as it aims to slow the progression of myopia (near-sightedness) and correct vision while you sleep.⁶ ⁷ ⁸ ⁹ ¹⁰

Eligibility Criteria

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.

Inclusion Criteria

I am not using any treatments to control nearsightedness.

Refractive error: spherical Component +2.00D to -5.00D; astigmatic Component up to -1.50D; non-presbyopic

1st year optometry student

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Exclusion Criteria

I am using treatments to control my nearsightedness.

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

Pregnancy

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Initial measurements of axial length and refractive error are taken before any intervention

1 visit

Treatment

Participants undergo orthokeratology fitting and follow-up measurements of axial length and refraction

3 years

Yearly visits for measurements

Follow-up

Participants are monitored for axial length progression and refractive changes after treatment

2 years

Treatment Details

Interventions

Orthokeratology

Trial Overview 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.

Participant Groups

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.