Back to resultsRecommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric
Primary Purpose
Cataract
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AcrySof® Toric IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Visual acuity,, corneal and, refractive, cylinder, following, implantation of the, AcrySof® Toric
Eligibility Criteria
Inclusion Criteria:
- 40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.
Exclusion Criteria:
- Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.
Sites / Locations
- Alcon Call Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
AcrySof® Toric IOL
Outcomes
Primary Outcome Measures
Corneal astigmatism; IOL rotation
Secondary Outcome Measures
Uncorrected and best distance corrected visual acuities (UCVA and BDCVA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00761488
Brief Title
Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Primary Investigator resigned from hospital
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
To allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of the AcrySof Toric IOL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Visual acuity,, corneal and, refractive, cylinder, following, implantation of the, AcrySof® Toric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AcrySof® Toric IOL
Intervention Type
Device
Intervention Name(s)
AcrySof® Toric IOL
Intervention Description
Implanted into the study eye
Primary Outcome Measure Information:
Title
Corneal astigmatism; IOL rotation
Time Frame
Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
Secondary Outcome Measure Information:
Title
Uncorrected and best distance corrected visual acuities (UCVA and BDCVA)
Time Frame
Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.
Exclusion Criteria:
Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.
Facility Information:
Facility Name
Alcon Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric
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