Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00759668
First received: September 24, 2008
Last updated: January 5, 2011
Last verified: January 2011
Results First Received: October 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cataract
Interventions: Device: Acrysof Natural ReSTOR SN60D3
Device: Acrysof Natural Monofocal SN60AT

  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
35 patients, diagnosed with bilateral cataracts age related, requiring extraction of cataracts in both eyes followed by implantation of a posterior chamber intraocular lens, were recruited.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients meeting the inclusion/exclusion criteria were enrolled.

Reporting Groups
  Description
SN60D3 Intraocular Lens Acrysof Natural Restor SN60D3
SN60AT Intraocular Lens Acrysof Natural Monofocal SN60AT

Participant Flow:   Overall Study
    SN60D3     SN60AT  
STARTED     17     18  
COMPLETED     16     15  
NOT COMPLETED     1     3  



  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.
No text entered.

Reporting Groups
  Description
SN60D3 Intraocular Lens Acrysof Natural Restor SN60D3
SN60AT Intraocular Lens Acrysof Natural Monofocal SN60AT
Total Total of all reporting groups

Baseline Measures
    SN60D3     SN60AT     Total  
Number of Participants  
[units: participants]
  17     18     35  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     6     9  
>=65 years     14     12     26  
Gender  
[units: participants]
     
Female     10     11     21  
Male     7     7     14  



  Outcome Measures
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1.  Primary:   Near Best Corrected Visual Acuity (BCVA) - Binocular   [ Time Frame: 6 months after second eye implantation ]

2.  Primary:   Near Uncorrected Visual Acuity (UCVA) Binocular   [ Time Frame: 6 months after second eye implantation ]

3.  Primary:   Near Best Corrected Visual Acuity Left Eye (BCVA LE)   [ Time Frame: 6 months after second eye implantation ]

4.  Primary:   Near Uncorrected Visual Acuity Left Eye (UCVA LE)   [ Time Frame: 6 months after second eye implantation ]

5.  Primary:   Near Best Corrected Visual Acuity Right Eye (BCVA RE)   [ Time Frame: 6 months after second eye implantation ]

6.  Primary:   Near Uncorrected Visual Acuity Right Eye (UCVA RE)   [ Time Frame: 6 months after second eye implantation ]


  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
Visual acuity data were collected in different units (i.e. c, twentieth, decimal, Jaeger) and were converted to LogMAR after inclusion in the database. This led to inevitable approximations of the data.  


Results Point of Contact:  
Name/Title: Marcello Fornoni
Organization: Alcon Italia SpA
phone: 39.02.81.303.226
e-mail: marcello.fornoni@alconlabs.com


No publications provided


Responsible Party: Marcello Fornoni, Alcon
ClinicalTrials.gov Identifier: NCT00759668     History of Changes
Other Study ID Numbers: IT 06 01
Study First Received: September 24, 2008
Results First Received: October 12, 2010
Last Updated: January 5, 2011
Health Authority: Italy: The Italian Medicines Agency