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

Bausch + Lomb

Status and phase

Completed

Phase 3

Conditions

Cataract

Aphakia

Treatments

Device: enVista

Study type

Interventional

Funder types

Industry

Identifiers

NCT01230060

658

Details and patient eligibility

About

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).

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.