Back to resultsVisual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL
Primary Purpose
Cataracts
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AcrySof ReSTOR Aspheric IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts focused on measuring Cataract, visual acuity, AcrySof ReSTOR Aspheric Intraoculare Lens, Bilateral cataract
Eligibility Criteria
Inclusion Criteria:
- Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
- 50~75 years of age
- <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.
Exclusion Criteria:
- Patients with pre-existing conditions that could skew the results.
- Any of conditions before and during surgery specified in the product information.
Sites / Locations
- Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ReSTOR Aspheric IOL
Arm Description
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Outcomes
Primary Outcome Measures
Uncorrected and Best Corrected Visual Acuities (Near and Distance)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00818116
Brief Title
Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL
Official Title
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Cataract, visual acuity, AcrySof ReSTOR Aspheric Intraoculare Lens, Bilateral cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReSTOR Aspheric IOL
Arm Type
Experimental
Arm Description
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Intervention Type
Device
Intervention Name(s)
AcrySof ReSTOR Aspheric IOL
Intervention Description
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.
Primary Outcome Measure Information:
Title
Uncorrected and Best Corrected Visual Acuities (Near and Distance)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
50~75 years of age
<1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.
Exclusion Criteria:
Patients with pre-existing conditions that could skew the results.
Any of conditions before and during surgery specified in the product information.
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 Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL
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