Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-30 @ 9:09 AM
Study NCT ID:
NCT06997003
Status:
RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Sponsor:
Bausch & Lomb GmbH
Organization:
Study Overview
Official Title:
Evaluation of a New Customized Corneal Treatment for Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Status:
RECRUITING
Status Verified Date:
2025-06
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:
Prospective, post market clinical follow up study with a three months postoperative follow up to evaluate the visual and refractive outcomes of OCTAVIUS treatment when used as intended.
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?: