Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-27 @ 3:07 AM
Study NCT ID:
NCT01763593
Status:
UNKNOWN
Last Update Posted:
2013-04-30
First Post:
2012-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Surgical Performance Study of Aurosleek Surgical Blades
Sponsor:
Aurolab
Organization:
Study Overview
Official Title:
A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients
Status:
UNKNOWN
Status Verified Date:
2013-04
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:
Aurosleek
Brief Summary:
To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.
Detailed Description:
Cataract till today remains the most common yet treatable cause of blindness accounting for more than 50% of blindness and visual impairment in the developing world. One of the most important features of a blade for cataract surgery is its predictable and repeatable behavior. The surgeon repeatedly and reliably needs to create similar tunnels of the proper length. Aurolab is producing surgical blades (Aurosleek) intended for making incision in cataract surgeries.
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?: