Back to resultsVisual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ReSTOR
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring ReSTOR Aspheric +3 IOL
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with cataracts
Exclusion Criteria:
- Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;
- <1 diopter astigmatism by keratometry readings.
Sites / Locations
- Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ReSTOR Aspheric +3
Arm Description
Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Outcomes
Primary Outcome Measures
Uncorrected Visual Acuity (UCVA)
Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00719732
Brief Title
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Official Title
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
ReSTOR Aspheric +3 IOL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReSTOR Aspheric +3
Arm Type
Experimental
Arm Description
Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Intervention Type
Device
Intervention Name(s)
ReSTOR
Intervention Description
Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Primary Outcome Measure Information:
Title
Uncorrected Visual Acuity (UCVA)
Description
Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosed with cataracts
Exclusion Criteria:
Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;
<1 diopter astigmatism by keratometry readings.
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
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