Orthokeratology for Near-sightedness

(ALWAOM Trial)

Enrolling by invitation at 1 trial location

Overseen By Bruce 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how orthokeratology, a special contact lens treatment, could control the worsening of near-sightedness (myopia) in adults. The treatment involves wearing custom-fitted lenses overnight to temporarily reshape the front of the eye, allowing clear vision during the day. The goal is to determine if this method can slow changes in eye length linked to worsening vision. Ideal candidates are first-year optometry students with near-sightedness who are not using treatments to control it and have no serious eye diseases. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new solutions for managing myopia.

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 prior data suggests that orthokeratology is safe for near-sightedness?

Research has shown that orthokeratology, a treatment using special contact lenses worn overnight, is generally safe. Studies indicate it can effectively slow the progression of nearsightedness by 40% to 60% compared to regular lenses. Orthokeratology is considered safe, particularly for children, but some risks exist. About 25% of users did not experience a benefit, and factors such as younger age or higher levels of nearsightedness can increase the likelihood of eye surface problems. Overall, while most people tolerate the treatment well, awareness of these potential risks is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Orthokeratology is unique because it uses specially designed contact lenses worn overnight to temporarily reshape the cornea and correct near-sightedness during the day. Unlike standard treatments like glasses or daytime contact lenses, orthokeratology offers a glasses-free experience throughout the day. Researchers are excited about this treatment because it not only corrects vision but also shows promise in slowing down the progression of myopia in children by reducing axial length growth. This dual benefit makes it a promising option for managing near-sightedness more effectively.

What evidence suggests that orthokeratology is effective for near-sightedness?

Research has shown that orthokeratology (ortho-k) effectively slows the progression of nearsightedness. Ortho-k involves wearing special contact lenses during sleep to temporarily reshape the front part of the eye. Studies have found that this treatment can reduce eye growth, which is linked to worsening nearsightedness, by about 30% to 60%. Specifically, in a three-year study, 70% of participants using Euclid Ortho-K lenses experienced only small changes in eye growth. This suggests that ortho-k lenses reliably control the progression of nearsightedness. Additionally, ortho-k has proven as effective as low-dose atropine eye drops in slowing nearsightedness. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Pregnancy

I am using treatments to control my nearsightedness.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Orthokeratology Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Art Optical Contact Lens, Inc.

Lead Sponsor

Trials

1

Recruited

100+

University of Missouri, St. Louis

Collaborator

Trials

15

Recruited

2,700+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39460594/

Myopia control with orthokeratology lenses. A 3-year follow ... Conclusion: The efficacy of myopia control by OKL was stable during 3 years of treatment. Similar treatment efficacies were found regardless of ...

2. myopiaprofile.com myopiaprofile.com/articles/Efficacy-and-Safety-of-Orthokeratology

Efficacy and safety of orthokeratology This article provides new insights into the efficacy and safety of orthokeratology (ortho-k) lenses in controlling myopia progression in ...

3. euclidlenses.com euclidlenses.com/three-year-study-reveals-efficacy-results-utilizing-euclid-ortho-k-lenses-for-myopia-management/

Three-year Study Reveals Results Utilizing Euclid Ortho-K ... Recent study reveals that Euclid Ortho-K Lenses at year three showed minimal axial length elongation in 70% of patients.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1367048423003338

Comparison of the clinical efficacy of orthokeratology and ... Ortho-k lenses and 0.01% atropine can achieve similar efficacy of myopia retardation, which was significantly better than that obtained with single-vision ...

5. eandv.biomedcentral.com eandv.biomedcentral.com/articles/10.1186/s40662-024-00403-3

Efficacy of orthokeratology lens with the modified small ... Orthokeratology (ortho-K) has gained considerable popularity in the last decade, with a myopia control efficacy of about 30% to 60% [6,7,8,9]. ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10179394/

Myopia Control Efficacy and Long-Term Safety of a Novel ... Myopia control efficacy of the OK lens was 52.3% over 1 year, and 37.1% over 2 years. This level of efficacy is comparable to efficacy reported ...

7. kosinmedj.org kosinmedj.org/journal/view.php?number=1265

Prevention of myopia progression using orthokeratology By addressing different mechanisms of myopia progression, Ortho-K has shown promising outcomes. Rapid advances in this technology have improved ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12174107/

Factors affecting myopia control outcomes with ... Recent clinical studies have reported that OrthoK lenses are 40%–60% more effective in slowing myopia progression compared to traditional single ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1367048420301661

The safety of orthokeratology in myopic children and ... Conclusions. Orthokeratology is a safe option for children with myopia. Younger age, higher myopia, and AC were risk factors for corneal AE in OK wearers.