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
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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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
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 ]

2.  Secondary:   Contrast Sensitivity   [ Time Frame: 6 Months ]

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

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


  Serious Adverse Events
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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

Serious Adverse Events
    Monofocal     Phakic  
Total, serious adverse events      
# participants affected / at risk     0/20 (0.00%)     0/32 (0.00%)  




  Other Adverse Events


  Limitations and Caveats
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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
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