NCT01230060

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Aphakia
• Cataract

Interventions

Type	Name	Description
DEVICE	enVista	One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-01-01
• Completion: 2011-08-01
• First posted: 2010-10-28
• Last updated: 2013-08-22
• Results posted: 2013-08-22

Locations

1 site across 1 country: United States