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Orthokeratology

Orthokeratology Lenses for Near-sightedness

N/A

Waitlist Available

Research Sponsored by Euclid Systems Corporation

Eligibility Criteria Checklist

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

Must have

Ages 6-35 (inclusive) and able to understand and assent to participation

Be younger than 65 years old

Must not have

Not able or willing to provide informed consent and assent

Subjects who have undergone corneal refractive surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare how comfortable Euclid orthokeratology lenses are with and without a special coating in 50 children. They will also track how much the children's eyes grow in size over time.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort while wearing the lenses, temporary visual disturbances, or minor eye irritation due to the coatings.

Eligibility Criteria

Inclusion Criteria

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

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I am between 6 and 35 years old and can understand and agree to participate.

Exclusion Criteria

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

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

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I have had surgery to correct my vision.

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I need medication for my eyes at the same time.

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I don't have any eye or systemic conditions that would prevent me from safely wearing contact lenses.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Lens wettability

Secondary study objectives

Patient comfort ratings

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Euclid orthokeartology (standard coating)Experimental Treatment1 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 Treatment1 Intervention

0 / 6Eligibility criteria met