Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT03708367
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2018-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Organization:
Study Overview
Official Title:
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
Status:
COMPLETED
Status Verified Date:
2021-03
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:
This is a post-market, prospective, randomized, multi-center, bilateral, open-label, cross-over, comparative clinical study. Study group will undergo preoperative LipiFlow treatment and Control group will not receive preoperative LipiFlow treatment. Three months postoperatively, both groups will be evaluated for clinical outcomes and the Control group will receive LipiFlow treatment as the cross-over group. The Control group will be evaluated at 4 months postoperative for clinical outcomes.
Detailed Description:
None
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?: