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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01230060
Recruitment Status : Completed
First Posted : October 28, 2010
Results First Posted : August 22, 2013
Last Update Posted : August 22, 2013
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Aphakia Cataract Device: enVista Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: enVista
enVista One-Piece Hydrophobic Acrylic Intraocular Lens
Device: enVista
One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01230060

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United States, California
Bausch & Lomb
Aliso Viejo, California, United States, 92656
Sponsors and Collaborators
Bausch & Lomb Incorporated
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Study Director: Mark Packer, MD,FACS Drs. Fine, Hoffman & Packer
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Responsible Party: Bausch & Lomb Incorporated Identifier: NCT01230060    
Other Study ID Numbers: 658
First Posted: October 28, 2010    Key Record Dates
Results First Posted: August 22, 2013
Last Update Posted: August 22, 2013
Last Verified: August 2013
Keywords provided by Bausch & Lomb Incorporated:
ocular surgery
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases