Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT02863159
Status:
UNKNOWN
Last Update Posted:
2016-08-11
First Post:
2016-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Assessment of the Full Range of Functional Vision With Three Tecnis Multifocal IOL 1-Piece Models in Bilateral Cataract Extraction
Sponsor:
Dell Laser Consultants
Organization:
Study Overview
Official Title:
A Clinical Assessment of the Full Range of Functional Vision (Distance, Intermediate, Near) With Three Tecnis Multifocal IOL 1-Piece Models [+2.75D (ZKB00), +3.25D (ZLB00), +4.00D (ZMB00)] in Subjects Undergoing Bilateral Cataract Extraction
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
RECRUITING
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 of this study is to evaluate the uncorrected binocular distance, intermediate, and near visual acuities, and assess patient's spectacle independence and satisfaction in individuals undergoing bilateral cataract extraction that have received two different arms of near add design IOLs of the same diffractive multifocal model.
Detailed Description:
This will be a multi-center, parallel comparison clinical study design with two treatment groups. One hundred (100) qualified study patients will receive a +2.75D (ZKB00) Tecnis Multifocal 1-Piece IOL in their dominant eye. Of these study patients, 50 patients will receive the +3.25D (ZLB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye and the other 50 patients will receive the +4.00D (ZMB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye. each study patient will undergo the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the first eye. In addition, as is customary for the surgeon, each study patient will receive the same open-label pre-operative, operative and post-operative medications over the course of the study period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: