Back to resultsLow Cylinder Toric
Primary Purpose
Cataracts
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Toric IOL (SN60T3)
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts focused on measuring Toric IOL
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Cataracts
- Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)
Exclusion Criteria:
- Preoperative ocular pathology
- Planned monovision
Sites / Locations
- Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AcrySof Toric T3
Arm Description
Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL)
Outcomes
Primary Outcome Measures
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Best Corrected Distance Visual Acuity
Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Residual Refractive Cylinder
Residual Refractive Cylinder at month 6 measured in diopters (D).
Secondary Outcome Measures
Patient Satisfaction Survey
Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00732030
Brief Title
Low Cylinder Toric
Official Title
Evaluation of the Acrysof Toric Model SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.03 Diopters (D)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 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
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Toric 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
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AcrySof Toric T3
Arm Type
Experimental
Arm Description
Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL)
Intervention Type
Device
Intervention Name(s)
Toric IOL (SN60T3)
Intervention Description
Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.
Primary Outcome Measure Information:
Title
Uncorrected Distance Visual Acuity
Description
Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Time Frame
6 months
Title
Best Corrected Distance Visual Acuity
Description
Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Time Frame
6 Months
Title
Residual Refractive Cylinder
Description
Residual Refractive Cylinder at month 6 measured in diopters (D).
Time Frame
6 Month
Secondary Outcome Measure Information:
Title
Patient Satisfaction Survey
Description
Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Cataracts
Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)
Exclusion Criteria:
Preoperative ocular pathology
Planned monovision
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
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Low Cylinder Toric
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