Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00721253
First received: July 21, 2008
Last updated: March 4, 2010
Last verified: March 2010
Results First Received: September 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Cataract
Interventions: Device: ReSTOR
Device: Tecnis
Device: Acri.LISA

  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

Subjects 18 years or older of either sex and any race; bilateral diagnosis of cataracts.

There were no patients that received implantation of the Tecnis Multifocal lens.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subject eligibility was determined at the pre-operative visit.

Reporting Groups
  Description
ReSTOR Aspheric +4 Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
Acri LISA IOL Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
Tecnis MF Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900

Participant Flow:   Overall Study
    ReSTOR Aspheric +4     Acri LISA IOL     Tecnis MF  
STARTED     20     22     0 [1]
COMPLETED     20     22     0  
NOT COMPLETED     0     0     0  
[1] There were no subjects that were implanted with the Tecnis lens.



  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.
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Reporting Groups
  Description
ReSTOR Aspheric +4 Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
Acri LISA IOL Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
Total Total of all reporting groups

Baseline Measures
    ReSTOR Aspheric +4     Acri LISA IOL     Total  
Number of Participants  
[units: participants]
  20     22     42  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     21     33  
>=65 years     8     1     9  
Gender  
[units: participants]
     
Female     12     15     27  
Male     8     7     15  



  Outcome Measures
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1.  Primary:   Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate   [ Time Frame: 6 months ]

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

3.  Secondary:   Defocus Curve   [ Time Frame: 6 months post-operative ]


  Serious Adverse Events


  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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  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.


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, Alcon
ClinicalTrials.gov Identifier: NCT00721253     History of Changes
Other Study ID Numbers: M07-002
Study First Received: July 21, 2008
Results First Received: September 18, 2009
Last Updated: March 4, 2010
Health Authority: Spain: Ministry of Health