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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
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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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
AcrySof Toric IOL AcrySof Toric Intraocular Lens
AcrySof Natural IOL AcrySof Natural Intraocular Lens
Total Total of all reporting groups

Baseline Measures
    AcrySof Toric IOL     AcrySof Natural IOL     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     15     27  
>=65 years     18     15     33  
Gender  
[units: participants]
     
Female     17     16     33  
Male     13     14     27  



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

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


  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: 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