One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
The objective of this study is to evaluate the safety and effectiveness of the enVista® One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens has been removed by an extracapsular cataract extraction method (eg, small incision phacoemulsification).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of a Bausch + Lomb One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction|
- Visual Acuity [ Time Frame: 120-180 days (visit 4) ] [ Designated as safety issue: No ]Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.
|Study Start Date:||October 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
enVista One-Piece Hydrophobic Acrylic Intraocular Lens
One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
|United States, California|
|Bausch & Lomb|
|Aliso Viejo, California, United States, 92656|
|Study Director:||Mark Packer, MD,FACS||Drs. Fine, Hoffman & Packer|