Euclid Phoenix Lens Design Trial

Status unconfirmed · Not applicable

Conditions studied: Myopia, Cornea

In brief

The "first fit" success rate of the current Euclid orthokeratology "MAX" lens design will be compared to that of the new Euclid orthokeratology MAX "Phoenix" lens design in 30 children.

Key facts

Study ID

NCT06389916

Run by

Euclid Systems Corporation

People needed

30

Starts

2023-11-01

Expected to finish

2024-04-01

Last updated by the study team

2024-04-29

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
• Sign written Informed Consent (and the California Bill of Rights, if applicable).
• Ages 6-18 (inclusive) and able to understand and assent to participation
• Have need of optical correction for myopia, from -1.00 to -5.00 dioptcrs (D).
• Have a refractive astigmatism of less than -1.50 D.
• Have a minimum Best Spectacle Corrected Visual Acuity (BSCVA) of 20/40 or better.
• Have reasonable expectations of improvement in visual acuity with the Euclid Orthokeratology Lens of 20/40 or better after overnight wear without corrective aids.
• Be at least 18 years old to give informed consent.
• Not a current or former wearer of orthokeratology lenses
• Not a current wearer of soft contact lenses
• Have acceptable or optimal fit with study lenses and be willing to wear these lenses as directed for the duration of the study.
• On examination, have ocular findings considered to be within normal limits
• Normal binocularity (no amblyopia or strabismus, and no anisometropia of greater than 2.00D)
• Be willing and able to follow instructions and attend the schedule of follow-up visits.

You may not qualify if…

• Does not meet the any of the above inclusion criteria
• Not able or willing to provide informed consent and assent
• Requires concurrent ocular medication
• Eye injury or surgery within twelve weeks immediately prior to enrollment
• Pre-existing ocular condition that would preclude contact lens fitting
• Currently enrolled in an ophthalmic clinical trial
• Pregnant or lactating or expect to become pregnant during the trial
• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Allergy or sensitivity to any product used in this trial
• Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by contact lenses.
• Strabismus/amblyopia
• Habitually uncorrected anisometropia ≥2.00
• Subjects who have undergone corneal refractive surgery
• Subjects with severe corneal irregularity contraindicating lens wear
• Inability to wear contact lenses, or an unacceptable contact lens fit
• Poor or unacceptable fit with any study lens

Where it is running

• Insight Vision Center Optometry — Costa Mesa, California, United States
• Dau Family Eye Care — Saint Johns, Florida, United States
• Cornea and Contact Lens Institute of Minnesota — Edina, Minnesota, United States
• Somerset Eye Care — North Brunswick, New Jersey, United States
• Treehouse Eyes — Tysons Corner, Virginia, United States

Full record on ClinicalTrials.gov

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