Status:
COMPLETED
One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Aphakia
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01230060
Start Date
October 1 2010
End Date
August 1 2011
Last Update
August 22 2013
Active Locations (1)
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1
Bausch & Lomb
Aliso Viejo, California, United States, 92656