Back to resultsVisual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AcrySof ReSTOR Aspheric IOL model SN6AD1
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Bilateral Cataract, IOL, ReSTOR, Aspheric
Eligibility Criteria
Inclusion Criteria:
- Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.
Exclusion Criteria:
- Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ReSTOR +3 Multifocal Lens
Arm Description
Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Outcomes
Primary Outcome Measures
Binocular Visual Acuity at Distance, Near and Intermediate
Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00710931
Brief Title
Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Official Title
Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Bilateral Cataract, IOL, ReSTOR, Aspheric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReSTOR +3 Multifocal Lens
Arm Type
Experimental
Arm Description
Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Intervention Type
Device
Intervention Name(s)
AcrySof ReSTOR Aspheric IOL model SN6AD1
Intervention Description
Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) following cataract removal.
Primary Outcome Measure Information:
Title
Binocular Visual Acuity at Distance, Near and Intermediate
Description
Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.
Exclusion Criteria:
Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
Facility Information:
Facility Name
Contact 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 With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
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