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Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

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ClinicalTrials.gov Identifier: NCT00759096
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Sponsor:
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
Enrollment 30
Recruitment Details Eligible patients with bilateral cataract were implanted with ReSTOR lens and followed up for 6-month after the 2nd eye implantation
Pre-assignment Details Open-label, single arm and nonrandomized
Arm/Group Title AcrySof ReSTOR IOL
Hide Arm/Group Description Acrysof ReSTOR Intraocular Lens (IOL)
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title AcrySof ReSTOR IOL
Hide Arm/Group Description Acrysof ReSTOR Intraocular Lens (IOL)
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  10.0%
>=65 years
27
  90.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
22
  73.3%
Male
8
  26.7%
1.Primary Outcome
Title Near Uncorrected Visual Acuity(UCVA
Hide Description Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.
Time Frame 6 months after surgery of 2nd eye
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AcrySof ReSTOR IOL
Hide Arm/Group Description:
Acrysof ReSTOR Intraocular Lens (IOL)
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: logMAR
0.5  (0.12)
2.Secondary Outcome
Title Contrast Sensitivity
Hide Description [Not Specified]
Time Frame 6 months after sugery of the 2nd eye
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AcrySof ReSTOR IOL
Hide Arm/Group Description Acrysof ReSTOR Intraocular Lens (IOL)
All-Cause Mortality
AcrySof ReSTOR IOL
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AcrySof ReSTOR IOL
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AcrySof ReSTOR IOL
Affected / at Risk (%)
Total   0/30 (0.00%) 
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.
ClinicalTrials.gov 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