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

NCT ID: NCT01230060

Last Updated: 2013-08-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Aphakia Cataract

Keywords

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ocular surgery phacoemulsification

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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enVista

enVista One-Piece Hydrophobic Acrylic Intraocular Lens

Group Type EXPERIMENTAL

enVista

Intervention Type DEVICE

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

Interventions

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enVista

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Packer, MD,FACS

Role: STUDY_DIRECTOR

Drs. Fine, Hoffman & Packer

Locations

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Bausch & Lomb

Aliso Viejo, California, United States

Site Status

Countries

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United States

Other Identifiers

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658

Identifier Type: -

Identifier Source: org_study_id