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

Primary Purpose

Aphakia, Cataract

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
enVista
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphakia focused on measuring ocular surgery, phacoemulsification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

enVista

Arm Description

enVista One-Piece Hydrophobic Acrylic Intraocular Lens

Outcomes

Primary Outcome Measures

Visual Acuity
Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2010
Last Updated
August 9, 2013
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01230060
Brief Title
One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Cataract
Keywords
ocular surgery, phacoemulsification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enVista
Arm Type
Experimental
Arm Description
enVista One-Piece Hydrophobic Acrylic Intraocular Lens
Intervention Type
Device
Intervention Name(s)
enVista
Intervention Description
One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.
Time Frame
120-180 days (visit 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Packer, MD,FACS
Organizational Affiliation
Drs. Fine, Hoffman & Packer
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb
City
Aliso Viejo
State/Province
California
ZIP/Postal Code
92656
Country
United States

12. IPD Sharing Statement

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

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