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Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

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ClinicalTrials.gov Identifier: NCT00818116
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : July 30, 2010
Last Update Posted : July 30, 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 Cataracts
Intervention Device: AcrySof ReSTOR Aspheric IOL
Enrollment 34
Recruitment Details 34 eligible patients were enrolled into the study
Pre-assignment Details Open-label, single arm, non-randomized
Arm/Group Title ReSTOR Aspheric
Hide Arm/Group Description Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Period Title: Overall Study
Started 34
Completed 34
Not Completed 0
Arm/Group Title ReSTOR Aspheric
Hide Arm/Group Description Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  41.2%
>=65 years
20
  58.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
24
  70.6%
Male
10
  29.4%
1.Primary Outcome
Title Uncorrected and Best Corrected Visual Acuities (Near and Distance)
Hide Description Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.
Time Frame 6 Months Following Cataract Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ReSTOR Aspheric
Hide Arm/Group Description:
Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: logMAR
Near Uncorrected Visual Acuity 0.02  (0.08)
Near Best-Corrected Visual Acuity 0.01  (0.07)
Distance Uncorrected Visual Acuity 0.00  (0.07)
Distance Best-Corrected Visual Acuity -0.03  (0.07)
Time Frame 1 Day, 1 Month, 3 Months, and 6 Months following cataract surgery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ReSTOR Aspheric
Hide Arm/Group Description Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
All-Cause Mortality
ReSTOR Aspheric
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ReSTOR Aspheric
Affected / at Risk (%) # Events
Total   0/34 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
ReSTOR Aspheric
Affected / at Risk (%) # Events
Total   1/34 (2.94%)    
Eye disorders   
Glare  1/34 (2.94%)  1
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
Layout table for Results Point of Contact information
Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 888.451.3937; 817.568.6725
EMail: medinfo@alconlabs.com
Layout table for additonal information
Responsible Party: China: Ethics Committee, Alcon China
ClinicalTrials.gov Identifier: NCT00818116     History of Changes
Other Study ID Numbers: CH-08-001
First Submitted: January 6, 2009
First Posted: January 7, 2009
Results First Submitted: June 30, 2010
Results First Posted: July 30, 2010
Last Update Posted: July 30, 2010