Orthokeratology Lenses for Near-sightedness

Not yet recruiting at 4 trial locations

Overseen By Tobin Ansel

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Euclid Systems Corporation

Must not be taking: Corticosteroids, Antimetabolites

Disqualifiers: Pregnancy, Autoimmune, Diabetes, Strabismus, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the comfort and effectiveness of two types of Euclid orthokeratology lenses for children with near-sightedness (myopia). Researchers aim to determine if the enhanced coating on one lens type improves comfort and eye health compared to the standard coating. Children aged 6-35 who currently wear Euclid orthokeratology lenses and require glasses for mild to moderate myopia might be suitable candidates. Participants will help scientists assess whether these lenses can slow the progression of near-sightedness. As an unphased trial, this study allows participants to contribute to important research that could enhance eye care for children.

Will I have to stop taking my current medications?

The trial requires that participants do not need concurrent ocular medication and excludes those using medications like corticosteroids and antimetabolites that may affect the eye. If you are on such medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that orthokeratology lenses, such as the Euclid lenses under study, are generally safe for correcting nearsightedness. Studies have found these lenses comfortable for both children and adults.

Published research suggests that Euclid lenses with the standard coating are safe and effective for treating nearsightedness and astigmatism, with few side effects reported.

For the version with the enhanced coating, similar studies have shown good patient acceptance and minimal side effects. Both versions are designed to fit comfortably on the eye, allowing for tear exchange, which helps maintain eye health.

Overall, these lenses are considered safe options for managing nearsightedness, with research supporting their comfort and safety over long periods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Euclid orthokeratology lenses because they offer a unique, non-surgical approach to temporarily reducing near-sightedness, also known as myopia. Unlike traditional glasses or daily wear contact lenses, these lenses are worn overnight to gently reshape the cornea, potentially reducing the need for daytime vision correction. The study is testing two versions: one with an enhanced coating that may improve comfort and lens performance. This innovative approach stands out by addressing myopia without the need for daytime eyewear, offering a convenient solution for those seeking freedom from glasses or contacts during the day.

What evidence suggests that this trial's treatments could be effective for near-sightedness?

This trial will compare Euclid orthokeratology lenses with enhanced coating to those with standard coating for managing myopia (near-sightedness). Studies have shown that Euclid orthokeratology lenses can effectively manage myopia by slowing eye growth. Research indicates that lenses with a special coating can limit vision changes to 0.25 diopters or less per year, demonstrating strong control over worsening eyesight. For lenses with the standard coating, one study found that 70% of patients experienced minimal eye growth over three years. Both types of lenses effectively slow myopia and are well-liked by patients. Overall, these lenses help improve vision and control myopia in both children and adults. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for children who are near-sighted and have healthy corneas. They must be willing to wear orthokeratology lenses and participate in regular check-ups to monitor the length of their eyes.

Inclusion Criteria

Have ocular findings considered to be within normal limits

Be willing and able to follow instructions and attend the schedule of follow-up visits

I am of legal age or have my guardian's consent to participate.

Exclusion Criteria

Subjects with severe corneal irregularity contraindicating lens wear

I have a misalignment of my eyes or a 'lazy eye'.

I am unable or unwilling to give my consent for participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Euclid orthokeratology lenses with either standard or enhanced coating

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Euclid orthokeratology (enhanced coating)
• Euclid orthokeratology (standard coating)

Trial Overview The study compares two types of Euclid orthokeratology lenses: one with an enhanced coating and another with a standard coating, focusing on lens comfort and effectiveness in slowing down eye growth.

How Is the Trial Designed?

Group I: Euclid orthokeartology (standard coating) Experimental Treatment 1 Intervention

Euclid Orthokeratology Contact Lenses are lathe cut contact lenses with spherical posterior surfaces. The posterior curve is selected to properly fit an individual eye for orthokeratology and the anterior curve is selected to provide the necessary optical power for a temporary reduction of myopia. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.

Group II: Euclid orthokeartology (enhanced coating) Experimental Treatment 1 Intervention

Euclid Orthokeratology Contact Lenses are lathe cut contact lenses with spherical posterior surfaces. The posterior curve is selected to properly fit an individual eye for orthokeratology and the anterior curve is selected to provide the necessary optical power for a temporary reduction of myopia. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.

Who Is Running the Clinical Trial?

Euclid Systems Corporation

Lead Sponsor

Trials

2

Recruited

80+

Citations

1. 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 ... In this study, Ortho-K treatment showed greater reduction in the amount of myopic refractive error change (less than or equal to 0.25D per year) compared to ...

2. reviewofmm.com reviewofmm.com/three-year-study-reveals-that-euclid-orthok-lenses-are-effective-for-myopia-management/

Three-Year Study Reveals That Euclid OrthoK Lenses Are ... This study demonstrates that Euclid Vision's proprietary designs can result in the successful management of myopia and strong patient acceptance.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12297005/

Long-Term Efficacy of CRT, Lucid, Euclid, and IBright ... The primary finding of this study is that all four types of OK lenses demonstrated comparable efficacy in controlling axial elongation and ...

4. withpower.com withpower.com/trial/orthokeratology-lenses-for-near-sightedness-427e0

Orthokeratology Lenses for Near-sightedness Studies have demonstrated improvements in visual quality and myopia control in both children and adults using these lenses.

5. reviewofmm.com reviewofmm.com/extensive-orthok-research-confirms-efficacy-to-slow-myopia-progression/

Extensive OrthoK Research Confirms Efficacy to Slow ... But, intriguingly, the two-year efficacy in that cohort of patients wearing the Euclid lens was virtually identical to what was found in the 12 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06392607

NCT06392607 | Euclid Phoenix Lens Design Trial 2 Lens wettability and subjective comfort of Euclid orthokeratology lenses with and without an enhanced coating will be compared in 50 children.