Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00759096
First received: September 23, 2008
Last updated: January 25, 2010
Last verified: January 2010
Results First Received: September 11, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Visual Acuity
Intervention: Device: RESTOR IOL Model SA60D3

  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
Eligible patients with bilateral cataract were implanted with ReSTOR lens and followed up for 6-month after the 2nd eye implantation

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open-label, single arm and nonrandomized

Reporting Groups
  Description
AcrySof ReSTOR IOL Acrysof ReSTOR Intraocular Lens (IOL)

Participant Flow:   Overall Study
    AcrySof ReSTOR IOL  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     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
AcrySof ReSTOR IOL Acrysof ReSTOR Intraocular Lens (IOL)

Baseline Measures
    AcrySof ReSTOR IOL  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     27  
Gender  
[units: participants]
 
Female     22  
Male     8  



  Outcome Measures

1.  Primary:   Near Uncorrected Visual Acuity(UCVA   [ Time Frame: 6 months after surgery of 2nd eye ]

2.  Secondary:   Contrast Sensitivity   [ Time Frame: 6 months after sugery of the 2nd eye ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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 NOT 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.


Results Point of Contact:  
Name/Title: Benny Li, PhD
Organization: Alcon Research, Ltd.
phone: +86 21 6375 8762
e-mail: Benny.Li@Alconlabs.com


No publications provided


Responsible Party: Benny Li, Ph.D., Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00759096     History of Changes
Other Study ID Numbers: MS-06-03
Study First Received: September 23, 2008
Results First Received: September 11, 2009
Last Updated: January 25, 2010
Health Authority: China: Ethics Committee