Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT03111550
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2017-04-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the Next-Generation Intraocular Lens
Sponsor:
Abbott Medical Optics
Organization:
Study Overview
Official Title:
Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
Status:
COMPLETED
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:
This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL.
The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.
The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.
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?:
None
Is an FDA AA801 Violation?: