NCT01230060CompletedPhase 3
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
Bausch & Lomb Incorporated1 site in 1 country122 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Visual Acuity
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
enVista
Experimental
enVista One-Piece Hydrophobic Acrylic Intraocular Lens
Intervention: enVista (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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