Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT04327518
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2020-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Rotational Stability of the Tecnis Toric II IOL
Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Organization:
Study Overview
Official Title:
Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens
Status:
COMPLETED
Status Verified Date:
2022-05
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:
STEELE
Brief Summary:
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?: