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Visual Function After Bilateral Implantation of AcrySof® Toric

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00758550
First received: September 23, 2008
Last updated: March 4, 2010
Last verified: March 2010
History of Changes
Results First Received: August 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Visual Function
Interventions: Device: AcrySof® Toric IOL
Device: AcrySof Natural

  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
60 cataract patients were enrolled into the study

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomized

Reporting Groups
  Description
AcrySof Toric IOL AcrySof Toric Intraocular Lens
AcrySof Natural IOL AcrySof Natural Intraocular Lens

Participant Flow:   Overall Study
    AcrySof Toric IOL     AcrySof Natural IOL  
STARTED     30     30  
COMPLETED     30     30  
NOT COMPLETED     0     0  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Uncorrected Visual Acuity (UCVA)   [ Time Frame: 6 Months after surgery ]
  Show Outcome Measure 1

2.  Secondary:   Questionnaire Results   [ Time Frame: 6 Months ]
  Show Outcome Measure 2


  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 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.


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
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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: Benny Li, Scientific Clinical Affairs Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00758550     History of Changes
Other Study ID Numbers: CM-06-17
Study First Received: September 23, 2008
Results First Received: August 13, 2009
Last Updated: March 4, 2010
Health Authority: China: Ethics Committee