Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT01615861
Status:
COMPLETED
Last Update Posted:
2019-11-14
First Post:
2012-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Sponsor:
Bausch & Lomb Incorporated
Organization:
Study Overview
Official Title:
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Status:
COMPLETED
Status Verified Date:
2019-11
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 objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases
* V4 (6M) endpoint: primary analysis
* V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis
* V4 (6M) endpoint: primary analysis
* V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis
Detailed Description:
None
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?: