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

NCT01230060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2013-08-22

Study results available
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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).

Conditions

  • Aphakia
  • Cataract

Interventions

DEVICE

enVista

One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Mark Packer, MD,FACS · Drs. Fine, Hoffman & Packer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-01-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230060 on ClinicalTrials.gov