Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT03579433
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2018-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Postmarket Study of an Intraocular Lens Power Selection System
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric
Status:
COMPLETED
Status Verified Date:
2020-04
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 purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.
Detailed Description:
Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.
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?: