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
Results First Received: May 16, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Aphakia
Cataract
Intervention: Device: enVista

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 6 clinical sites in the US. Study started Aug 2010 and was completed June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
122 subjects underwent cataract extraction and implantation of the Bausch + Lomb Intraocular Lens (IOL) for the correction of aphakia.

Reporting Groups
  Description
enVista

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.


Participant Flow:   Overall Study
    enVista  
STARTED     122  
COMPLETED     121  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All implanted eyes

Reporting Groups
  Description
enVista

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.


Baseline Measures
    enVista  
Number of Participants  
[units: participants]
  122  
Age  
[units: years]
Mean ± Standard Deviation
  69.0  ± 8.0  
Gender  
[units: participants]
 
Female     69  
Male     53  
Region of Enrollment  
[units: participants]
 
United States     122  



  Outcome Measures

1.  Primary:   Visual Acuity   [ Time Frame: 120-180 days (visit 4) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Jon Hayashida
Organization: Bausch & Lomb Incorporated
phone: (949) 521-7876
e-mail: jon.hayashida@bausch.com


No publications provided


Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01230060     History of Changes
Other Study ID Numbers: 658
Study First Received: October 27, 2010
Results First Received: May 16, 2013
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration