Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:47 AM
Study NCT ID:
NCT04969406
Status:
TERMINATED
Last Update Posted:
2022-06-10
First Post:
2021-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Trial of the Intelon BOSS(TM) System
Sponsor:
Intelon Optics, Inc
Organization:
Study Overview
Official Title:
A Prospective Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(TM) System
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment Difficulty
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: