Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01510717
First received: January 12, 2012
Last updated: May 8, 2015
Last verified: May 2015
Results First Received: May 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cataracts
Interventions: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Device: AcrySof® IQ Monofocal IOL Model 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
Participants were recruited and enrolled from 15 investigative sites located in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 409 participants enrolled, 80 were discontinued prior to randomization as screen failures and 9 were discontinued after randomization prior to implantation. This reporting group includes all participants with successful IOL implantation in at least 1 eye (320).

Reporting Groups
  Description
Multifocal IOL AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Monofocal IOL AcrySof® IQ Monofocal IOL Model SN60WF

Participant Flow:   Overall Study
    Multifocal IOL     Monofocal IOL  
STARTED     155     165  
COMPLETED     153     160  
NOT COMPLETED     2     5  
Adverse Event                 1                 2  
Death                 1                 0  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 0                 2  



  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.
This analysis population includes all participants with successful IOL implantation in at least 1 eye.

Reporting Groups
  Description
Multifocal IOL AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Monofocal IOL AcrySof® IQ Monofocal IOL Model SN60WF
Total Total of all reporting groups

Baseline Measures
    Multifocal IOL     Monofocal IOL     Total  
Number of Participants  
[units: participants]
  155     165     320  
Age  
[units: years]
Mean (Standard Deviation)
  68.7  (9.64)     69.4  (8.27)     69.0  (8.95)  
Age, Customized  
[units: participants]
     
20-29 years     1     0     1  
30-39 years     2     0     2  
40-49 years     2     3     5  
50-59 years     18     12     30  
60-69 years     53     62     115  
70-79 years     65     71     136  
≥80 years     14     17     31  
Gender  
[units: participants]
     
Female     96     97     193  
Male     59     68     127  
Region of Enrollment  
[units: participants]
     
United States     155     165     320  



  Outcome Measures
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1.  Primary:   Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180   [ Time Frame: Day 120-180 from second eye implantation ]

2.  Primary:   Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180   [ Time Frame: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation ]

3.  Primary:   Photopic Contrast Sensitivity Without Glare at Day 120-180   [ Time Frame: Day 120-180 from second eye implantation ]

4.  Primary:   Photopic Contrast Sensitivity With Glare at Day 120-180   [ Time Frame: Day 120-180 from second eye implantation ]

5.  Primary:   Mesopic Contrast Sensitivity Without Glare at Day 120-180   [ Time Frame: Day 120-180 from second eye implantation ]

6.  Primary:   Mesopic Contrast Sensitivity With Glare at Day 120-180   [ Time Frame: Day 120-180 from second eye implantation ]

7.  Secondary:   Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180   [ Time Frame: Day 120-180 from second eye implantation ]

8.  Secondary:   Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180   [ Time Frame: Day 120-180 from second eye implantation ]

9.  Secondary:   Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180   [ Time Frame: Day 120-180 from second eye implantation ]

10.  Secondary:   Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180   [ Time Frame: Day 120-180 from second eye implantation ]


  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 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: Magda Michna, PhD
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: NCT01510717     History of Changes
Other Study ID Numbers: C-10-016
Study First Received: January 12, 2012
Results First Received: May 8, 2015
Last Updated: May 8, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board