Euclid Phoenix Lens Design Trial

NCT06389916 | Active Not Recruiting FDA Device

• 1 other identifier: EU-PHX-RCT-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Myopia; Cornea

Outcome Measures

Primary Outcomes (1)

• First fit success rate

  Percentage of children successfully fit in the first lens pair ordered (as determined by the PI)

  1 month

Study Arms (2)

Euclid orthokeratology MAX (current design)

EXPERIMENTAL

Euclid Orthokeratology (oprifocon A) 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.

Device: Euclid orthokeratology MAX (current design)

Euclid orthokeratology MAX Phoenix (new design)

EXPERIMENTAL

Euclid Orthokeratology (oprifocon A) 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.

Device: Euclid orthokeratology MAX Phoenix (new design)

Interventions

Euclid orthokeratology MAX (current design) DEVICE

The current lens design

Euclid orthokeratology MAX (current design)

Euclid orthokeratology MAX Phoenix (new design) DEVICE

The new lens design

Euclid orthokeratology MAX Phoenix (new design)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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:

• 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

Sponsors & Collaborators

• Euclid Systems Corporation: lead

Study Sites (5)

Insight Vision Center Optometry

Costa Mesa, California, 92626, United States

Location

Dau Family Eye Care

Saint Johns, Florida, 32259, United States

Location

Cornea and Contact Lens Institute of Minnesota

Edina, Minnesota, 55436, United States

Location

Somerset Eye Care

North Brunswick, New Jersey, 08902, United States

Location

Treehouse Eyes

Tysons Corner, Virginia, 22182, United States

Location

MeSH Terms

Conditions

Myopia; Corneal Diseases

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: April 29, 2024
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

US (5)