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

Completed · Phase 3

Conditions studied: Aphakia, Cataract

In brief

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).

Key facts

Study ID

NCT01230060

Run by

Bausch & Lomb Incorporated

People needed

122

Starts

2010-10-01

Expected to finish

2011-08-01

Last updated by the study team

2013-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bausch & Lomb — Aliso Viejo, California, United States

Full record on ClinicalTrials.gov

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