A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01225926
First received: October 20, 2010
Last updated: September 24, 2013
Last verified: September 2013
Results First Received: July 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Cataract
Interventions: Device: Toric T3 - T9
Device: IQ SN60WF

  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 were recruited from one study center located in Russia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Toric T3 - T9 AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
IQ SN60WF AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.

Participant Flow:   Overall Study
    Toric T3 - T9     IQ SN60WF  
STARTED     12     12  
COMPLETED     12     12  
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.
No text entered.

Reporting Groups
  Description
Toric T3 - T9 AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
IQ SN60WF AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
Total Total of all reporting groups

Baseline Measures
    Toric T3 - T9     IQ SN60WF     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: years]
Mean ± Standard Deviation
  48.2  ± 18.64     55.5  ± 16.52     51.8  ± 17.63  
Gender  
[units: participants]
     
Female     7     8     15  
Male     5     4     9  



  Outcome Measures

1.  Primary:   Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3   [ Time Frame: Month 3 ]


  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
This study was considered a pilot study and did not have an expectation to meet any of the study endpoints.


  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: Manoj Venkiteshwar, Brand Lead, Global Medical Affairs
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01225926     History of Changes
Other Study ID Numbers: M10-003
Study First Received: October 20, 2010
Results First Received: July 22, 2013
Last Updated: September 24, 2013
Health Authority: Russia: Ethics Committee