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ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00684138
First received: May 22, 2008
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
Results First Received: January 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Cataract
Interventions: Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens

  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
Only adult subjects of either gender or any race in need of cataract extraction in both eyes were considered for enrollment. 280 subjects were implanted bilaterally with either the ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 or the ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 based upon a 1:1 randomization.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.

Reporting Groups
  Description
ACRYSOF® ReSTOR® +3.0 ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
ACRYSOF® ReSTOR® Aspheric +4.0 ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

Participant Flow:   Overall Study
    ACRYSOF® ReSTOR® +3.0     ACRYSOF® ReSTOR® Aspheric +4.0  
STARTED     141     139  
COMPLETED     138     131  
NOT COMPLETED     3     8  



  Baseline Characteristics
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Reporting Groups
  Description
ACRYSOF® ReSTOR® +3.0 ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
ACRYSOF® ReSTOR® Aspheric +4.0 ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Total Total of all reporting groups

Baseline Measures
    ACRYSOF® ReSTOR® +3.0     ACRYSOF® ReSTOR® Aspheric +4.0     Total  
Number of Participants  
[units: participants]
 		  141     139     280  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     51     40     91  
>=65 years     90     99     189  
Gender  
[units: participants]
 		     
Female     95     97     192  
Male     46     42     88  



  Outcome Measures
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1.  Primary:   Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)   [ Time Frame: 3 months ]
  Show Outcome Measure 1

2.  Secondary:   Binocular Distance Corrected Distance Visual Acuity   [ Time Frame: 3 months post-operative ]
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3.  Secondary:   Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)   [ Time Frame: 3 months post-operative ]
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4.  Secondary:   Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)   [ Time Frame: 3 months post-operative ]
  Show Outcome Measure 4

5.  Secondary:   Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)   [ Time Frame: 3 months post-operative ]
  Show Outcome Measure 5


  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
Data from one investigator, who implanted 20 subjects, were excluded from analysis due to non compliance with data collection and documentation. This resulted in 280 implanted subjects that were considered evaluable.  


Results Point of Contact:  
Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Tonya Tubbs Jones, Alcon
ClinicalTrials.gov Identifier: NCT00684138     History of Changes
Other Study ID Numbers: C-06-40
Study First Received: May 22, 2008
Results First Received: January 30, 2009
Last Updated: July 6, 2010
Health Authority: United States: Food and Drug Administration