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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01230060
First received: October 27, 2010
Last updated: August 9, 2013
Last verified: August 2013

October 27, 2010
August 9, 2013
October 2010
January 2011   (final data collection date for primary outcome measure)
Visual Acuity [ Time Frame: 120-180 days (visit 4) ] [ Designated as safety issue: No ]
Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.
Not Provided
Complete list of historical versions of study NCT01230060 on ClinicalTrials.gov Archive Site
Not Provided
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One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
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

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).

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aphakia
  • Cataract
Device: enVista
One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Experimental: enVista
enVista One-Piece Hydrophobic Acrylic Intraocular Lens
Intervention: Device: enVista
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
August 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01230060
658
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Mark Packer, MD,FACS Drs. Fine, Hoffman & Packer
Bausch & Lomb Incorporated
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP