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Blue Light Intraocular Lenses (IOLs) and Photostress

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00710996
First received: July 3, 2008
Last updated: January 29, 2010
Last verified: January 2010
History of Changes
Results First Received: September 18, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Cataract

  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
Patients with existing bilateral intraocular lenses (IOLs) of given type, age-matched patients with normal vision and no cataract surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.

Reporting Groups
  Description
AcrySof Natural Intraocular Lens AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN"
AcrySof Clear Intraocular Lens AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA"
Phakic Patients Phakic patients - Age matched patients who have not had cataract surgery

Participant Flow:   Overall Study
    AcrySof Natural Intraocular Lens     AcrySof Clear Intraocular Lens     Phakic Patients  
STARTED     17     20     21  
COMPLETED     16     16     21  
NOT COMPLETED     1     4     0  



  Baseline Characteristics
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Reporting Groups
  Description
AcrySof Natural Intraocular Lens AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN"
AcrySof Clear Intraocular Lens AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA"
Phakic Patients Phakic patients - Age matched patients who have not had cataract surgery
Total Total of all reporting groups

Baseline Measures
    AcrySof Natural Intraocular Lens     AcrySof Clear Intraocular Lens     Phakic Patients     Total  
Number of Participants  
[units: participants]
 		  17     20     21     58  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     2     2     3     7  
>=65 years     15     18     18     51  
Gender  
[units: participants]
 		       
Female     11     13     10     34  
Male     6     7     11     24  



  Outcome Measures

1.  Primary:   Photostress Recovery Time in Seconds.   [ Time Frame: 3 months ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  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: Rick Potvin
Organization: Alcon Research, Ltd.
phone: 817-551-4815
e-mail: Rick.Potvin@alconlabs.com


No publications provided by Alcon Research

Publications automatically indexed to this study:


Responsible Party: Rick Potvin, Alcon Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00710996     History of Changes
Other Study ID Numbers: M07-023
Study First Received: July 3, 2008
Results First Received: September 18, 2009
Last Updated: January 29, 2010
Health Authority: United States: Food and Drug Administration