Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389916
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-10-31
Brief Title:
Euclid Phoenix Lens Design Trial
Sponsor:
Euclid Systems Corporation
Organization:
Euclid Systems Corporation
Study Overview
Official Title:
Euclid Phoenix Lens Design Trial Phase 1
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None