Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

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: NCT00759096
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Information provided by:
Alcon Research

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Visual Acuity
Intervention: Device: RESTOR IOL Model SA60D3

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible patients with bilateral cataract were implanted with ReSTOR lens and followed up for 6-month after the 2nd eye implantation

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open-label, single arm and nonrandomized

Reporting Groups
AcrySof ReSTOR IOL Acrysof ReSTOR Intraocular Lens (IOL)

Participant Flow:   Overall Study
    AcrySof ReSTOR IOL

  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.
No text entered.

Reporting Groups
AcrySof ReSTOR IOL Acrysof ReSTOR Intraocular Lens (IOL)

Baseline Measures
   AcrySof ReSTOR IOL 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   27 
[Units: Participants]
Female   22 
Male   8 

  Outcome Measures

1.  Primary:   Near Uncorrected Visual Acuity(UCVA   [ Time Frame: 6 months after surgery of 2nd eye ]

2.  Secondary:   Contrast Sensitivity   [ Time Frame: 6 months after sugery of the 2nd eye ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  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
No text entered.

  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: Benny Li, PhD
Organization: Alcon Research, Ltd.
phone: +86 21 6375 8762

Responsible Party: Benny Li, Ph.D., Alcon Research Ltd. Identifier: NCT00759096     History of Changes
Other Study ID Numbers: MS-06-03
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: September 11, 2009
Results First Posted: February 10, 2010
Last Update Posted: February 10, 2010