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

Phase 3

Completed

• Conditions: Aphakia; Cataract
• Interventions: Device: enVista

• Registration Number: NCT01230060
• Lead Sponsor: Bausch & Lomb Incorporated

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 Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Primary Completion: 2011-01
• Study Completion: 2011-08
• Results First Submitted: 2013-05-16
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-09
• Last Update Submitted: 2013-08-09
• Results First Posted: 2013-08-22
• Last Update Posted: 2013-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
• Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40 in the study eye, with or without a glare source.
• Subjects must have a BCVA projected to be better than 20/30 after IOL implantation in the study eye.

Exclusion Criteria

• Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
• Subjects with any other serious ocular pathology, or underlying serious medical conditions, which based on the Investigator's medical judgment, could confound the results of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
enVista	enVista	enVista One-Piece Hydrophobic Acrylic Intraocular Lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity	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.

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Aliso Viejo, California, United States