NCT06389916

Euclid Phoenix Lens Design Trial

Euclid Phoenix Lens Design Trial Phase 1

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Euclid Systems Corporation · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of this trial is to provide an assessment of the "first fit" success of the Euclid orthokeratology "Phoenix" lens design versus its current "MAX" lens design when used by practitioners with moderate experience with fitting Euclid MAX orthokeratology lenses. The hypothesis to be tested is that the "first fit" success of the redesign Euclid MAX "Phoenix" lens design is greater than that of the current MAX lens design. The primary outcome variable is the percentage of participants successfully fit with the first lenses empirically ordered for the existing MAX lens design versus a modified MAX lens ("Phoenix") design. This clinical investigation will be a prospective, randomized, double-masked two-arm non-crossover trial.

Conditions

• Myopia
• Cornea

Interventions

Type	Name	Description
DEVICE	Euclid orthokeratology MAX (current design)	The current lens design
DEVICE	Euclid orthokeratology MAX Phoenix (new design)	The new lens design

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2024-04-29
• Last updated: 2024-04-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study