Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00366405
Status:
COMPLETED
Last Update Posted:
2010-10-04
First Post:
2006-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Torsional Handpiece to Conventional Handpiece During Routine Phacoemulsification
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Comparison of the Torsional Handpiece to Conventional Handpiece During Routine Phacoemulsification
Status:
COMPLETED
Status Verified Date:
2010-10
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 this study is to evaluate the visual outcomes, amount of inflammation, endothelial cell loss, and the efficiency of a torsional handpiece compared to a conventional handpiece during surgery to remove your cataracts.
Detailed Description:
With the introduction of new phaco-emulsification systems, the cataract surgery has become a very safe procedure. The new machines combine fewer surges, lower amount of ultrasound and more controlled anterior chamber depth, as well as lower incidence of thermal burns of the incision site.1-4
Alcon's Infiniti Vision System phacoemulsification machine includes now a torsional handpiece (OZiL™). The goal of OZiL™ is to minimize the surgery impact by reducing temperature increase, turbulence and incision stress. This handpiece has a sideways movement that does not repel the cataract during its extraction making the removal more continuous, maintains occlusion which facilitates vacuum build-up and reduces flow through the anterior chamber decreasing turbulence, therefore reducing the likelihood of lens particles damaging the corneal endothelial cells.
The purpose of this study is to compare visual outcomes, induction of inflammation, endothelial cell loss and efficiency of the torsional handpiece vs. the conventional phacoemulsification handpiece when using the Alcon Infiniti Vision System.
Alcon's Infiniti Vision System phacoemulsification machine includes now a torsional handpiece (OZiL™). The goal of OZiL™ is to minimize the surgery impact by reducing temperature increase, turbulence and incision stress. This handpiece has a sideways movement that does not repel the cataract during its extraction making the removal more continuous, maintains occlusion which facilitates vacuum build-up and reduces flow through the anterior chamber decreasing turbulence, therefore reducing the likelihood of lens particles damaging the corneal endothelial cells.
The purpose of this study is to compare visual outcomes, induction of inflammation, endothelial cell loss and efficiency of the torsional handpiece vs. the conventional phacoemulsification handpiece when using the Alcon Infiniti Vision System.
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?: