Clinical Trial: One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome: Visual Acuity [ Time Frame: 120-180 days (visit 4) ]

Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bausch & Lomb Incorporated

Dates:
Date Received: October 27, 2010
Date Started: October 2010
Date Completion:
Last Updated: August 9, 2013
Last Verified: August 2013