AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01605877
First received: May 22, 2012
Last updated: June 8, 2015
Last verified: June 2015
Results First Received: May 8, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cataracts
Intervention: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

  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 2 study sites located in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 70 subjects enrolled, 6 were discontinued prior to first implantation due to withdrawn consent (1) and meeting exclusion criteria (5). This reporting group includes all implanted subjects (64).

Reporting Groups
  Description
SN6AD2 AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation

Participant Flow:   Overall Study
    SN6AD2  
STARTED     64  
COMPLETED     63  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  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 implanted subjects.

Reporting Groups
  Description
SN6AD2 AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation

Baseline Measures
    SN6AD2  
Number of Participants  
[units: participants]
  64  
Age  
[units: years]
Mean (Standard Deviation)
  66.7  (7.2)  
Age, Customized  
[units: participants]
 
<60 years     10  
60-69 years     29  
70-79 years     24  
≥ 80 years     1  
Gender  
[units: participants]
 
Female     41  
Male     23  
Region of Enrollment  
[units: participants]
 
Japan     64  



  Outcome Measures
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1.  Primary:   Uncorrected Decimal VA (5 m)   [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ]

2.  Primary:   Uncorrected Decimal VA (50 cm)   [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ]

3.  Primary:   Best Corrected Decimal VA (5 m)   [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ]

4.  Primary:   Best Corrected Decimal VA (50 cm)   [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ]

5.  Primary:   Distance-Corrected Decimal VA (50 cm)   [ Time Frame: Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420 ]

6.  Secondary:   Uncorrected Decimal VA (1 m)   [ Time Frame: Day 120-180, Day 330-420 ]

7.  Secondary:   Distance Corrected Decimal VA (1 m)   [ Time Frame: Day 120-180, Day 330-420 ]

8.  Secondary:   Uncorrected Decimal VA (40 cm)   [ Time Frame: Day 120-180, Day 330-420 ]

9.  Secondary:   Distance Corrected Decimal VA (40 cm)   [ Time Frame: Day 120-180, Day 330-420 ]

10.  Secondary:   Uncorrected Decimal VA at Best Distance   [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ]

11.  Secondary:   Mean Best Distance (cm) for Uncorrected Decimal Near VA   [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ]

12.  Secondary:   Mean Best Distance (cm) for Distance Corrected Decimal Near VA   [ Time Frame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ]

13.  Secondary:   Best Corrected Far (3 m) Contrast Sensitivity   [ Time Frame: Day 120-180 from second eye implantation ]

14.  Secondary:   Best Corrected Near (46 cm) Contrast Sensitivity   [ Time Frame: Day 120-180 from second eye implantation ]

15.  Secondary:   Mean Defocus Decimal VA (5 m)   [ Time Frame: Day 120-180 from second eye implantation ]

16.  Secondary:   Percentage of Participants With Positive Response, Stereoscopic Vision Test   [ Time Frame: Day 120-180 from second eye implantation ]

17.  Secondary:   Percentage of Participants With Positive Response, Quality of Life Questions   [ 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: Hiroshi Kodama, Group Manager
Organization: Alcon Japan, Ltd.
phone: 81-3-6899-5000


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01605877     History of Changes
Other Study ID Numbers: J-11-037
Study First Received: May 22, 2012
Results First Received: May 8, 2015
Last Updated: June 8, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Institutional Review Board