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Contralateral ReSTOR / Monofocal or Phakic Eye

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00731640
First received: August 7, 2008
Last updated: March 19, 2010
Last verified: March 2010
History of Changes
Results First Received: September 9, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cataracts
Intervention: Device: ReSTOR

  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 is a retrospective study that required patients with unilateral implantation of the AcrySof ReSTOR Intraocular Lens (IOL). Patients were to be free of conditions or ocular co-morbidities that may affect visual acuity.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. This study was not randomized.

Reporting Groups
  Description
Monofocal Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
Phakic Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending

Participant Flow:   Overall Study
    Monofocal     Phakic  
STARTED     20     32  
COMPLETED     20     32  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Monofocal Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
Phakic Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Total Total of all reporting groups

Baseline Measures
    Monofocal     Phakic     Total  
Number of Participants  
[units: participants]
 		  20     32     52  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     8     23     31  
>=65 years     12     9     21  
Gender  
[units: participants]
 		     
Female     9     13     22  
Male     11     19     30  



  Outcome Measures
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1.  Primary:   Visual Acuity   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Contrast Sensitivity   [ Time Frame: 6 Months ]
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Measure Type Secondary
Measure Title Contrast Sensitivity
Measure Description Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Time Frame 6 Months  
Safety Issue No  

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
Monofocal Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
Phakic Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending

Measured Values
    Monofocal     Phakic  
Number of Participants Analyzed  
[units: participants]
 		  20     32  
Contrast Sensitivity  
[units: Log Units]
Mean ± Standard Deviation 		   
Photopic CS, 3 cycles per degree (cpd)     1.95  ± 0.13     1.90  ± 0.13  
Mesopic CS, 3 cpd     1.85  ± 0.18     1.84  ± 0.19  
Mesopic w/Glare CS, 3 cpd     1.82  ± 0.18     1.81  ± 0.22  
Photopic CS, 6 cpd     2.10  ± 0.24     2.05  ± 0.20  
Mesopic CS, 6 cpd     1.76  ± 0.36     1.62  ± 0.39  
Mesopic w/Glare CS, 6 cpd     1.73  ± 0.23     1.57  ± 0.56  
Photopic CS, 12 cpd     1.78  ± 0.26     1.66  ± 0.27  
Mesopic CS, 12 cpd     1.18  ± 0.51     0.95  ± 0.51  
Mesopic w/Glare CS, 12 cpd     1.21  ± 0.38     0.88  ± 0.54  
Photopic CS, 18 cpd     1.18  ± 0.39     1.14  ± 0.31  
Mesopic CS, 18 cpd     0.61  ± 0.52     0.49  ± 0.58  
Mesopic w/Glare CS, 18 cpd     0.57  ± 0.41     0.40  ± 0.52  

No statistical analysis provided for Contrast Sensitivity



3.  Secondary:   Patient Satisfaction   [ Time Frame: 6 Months Postoperative ]
  Show Outcome Measure 3

4.  Secondary:   Spectacle Independence   [ Time Frame: 6 Months ]
  Show Outcome Measure 4


  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: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier: NCT00731640     History of Changes
Other Study ID Numbers: M07-012
Study First Received: August 7, 2008
Results First Received: September 9, 2009
Last Updated: March 19, 2010
Health Authority: United States: Institutional Review Board