Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-30 @ 4:26 AM
Study NCT ID:
NCT05501795
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2022-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200
Sponsor:
Stephen Wexler
Organization:
Study Overview
Official Title:
The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200
Status:
COMPLETED
Status Verified Date:
2024-06
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:
The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.
Detailed Description:
This study is a Single site, single-arm, prospective, observational study of the accuracy of the intended flap thickness, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 day post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and flap thickness, and flap diameter.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: