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

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ClinicalTrials.gov Identifier: NCT01230060
Recruitment Status : Completed
First Posted : October 28, 2010
Results First Posted : August 22, 2013
Last Update Posted : August 22, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Aphakia
Cataract
Intervention Device: enVista
Enrollment 122
Recruitment Details This study was conducted at 6 clinical sites in the US. Study started Aug 2010 and was completed June 2011.
Pre-assignment Details 122 subjects underwent cataract extraction and implantation of the Bausch + Lomb Intraocular Lens (IOL) for the correction of aphakia.
Arm/Group Title enVista
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enVista One-Piece Hydrophobic Acrylic Intraocular Lens

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

Period Title: Overall Study
Started 122
Completed 121
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title enVista
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enVista One-Piece Hydrophobic Acrylic Intraocular Lens

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

Overall Number of Baseline Participants 122
Hide Baseline Analysis Population Description
All implanted eyes
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants
69.0  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants
Female
69
  56.6%
Male
53
  43.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 122 participants
122
1.Primary Outcome
Title Visual Acuity
Hide 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)
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Hide Analysis Population Description
All non missing implanted eyes, consistent set
Arm/Group Title enVista
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enVista One-Piece Hydrophobic Acrylic Intraocular Lens

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

Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: Participants
108
Time Frame 140-180 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title enVista
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enVista One-Piece Hydrophobic Acrylic Intraocular Lens

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

All-Cause Mortality
enVista
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
enVista
Affected / at Risk (%) # Events
Total   1/122 (0.82%)    
Blood and lymphatic system disorders   
Acute myeloid leukemia  1  1/122 (0.82%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
enVista
Affected / at Risk (%) # Events
Total   0/122 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Jon Hayashida
Organization: Bausch & Lomb Incorporated
Phone: (949) 521-7876
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01230060     History of Changes
Other Study ID Numbers: 658
First Submitted: October 27, 2010
First Posted: October 28, 2010
Results First Submitted: May 16, 2013
Results First Posted: August 22, 2013
Last Update Posted: August 22, 2013