Visual Function After Bilateral Implantation of AcrySof® Toric

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758550
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Information provided by:
Alcon Research

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Visual Function
Interventions: Device: AcrySof® Toric IOL
Device: AcrySof Natural

  Participant Flow

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

Reporting Groups
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   12   15   27 
>=65 years   18   15   33 
[Units: Participants]
Female   17   16   33 
Male   13   14   27 

  Outcome Measures

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

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

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

Responsible Party: Benny Li, Scientific Clinical Affairs Manager, Alcon Research Ltd. Identifier: NCT00758550     History of Changes
Other Study ID Numbers: CM-06-17
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: August 13, 2009
Results First Posted: March 16, 2010
Last Update Posted: March 16, 2010