Back to resultsRotational Stability of the AcrySof® Toric
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AcrySof® Toric intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract
Eligibility Criteria
Inclusion Criteria:
- Monolateral or bilateral cataracts
- anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D
- 0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
- able to sign the informed consent, to comply with scheduled visits and other study procedures
Exclusion Criteria:
- Preoperative ocular pathology
- previous intraocular or corneal surgery
- an increased risk for complications which could require vitreoretinal surgery
- corneal irregularities
- corneal opacities
- current contact lens usage
- uncontrolled diabetes
Sites / Locations
- Alcon Call Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Toric
Arm Description
Implantation with the AcrySof® Toric intraocular lens
Outcomes
Primary Outcome Measures
Rotational Stability
Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.
Secondary Outcome Measures
Residual Refractive Cylinder
The refractive astigmatism 6 months post-surgery, measured in diopters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00762216
Brief Title
Rotational Stability of the AcrySof® Toric
Official Title
Rotational Stability of the AcrySof® Toric
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
undefined (undefined)
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
To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toric
Arm Type
Other
Arm Description
Implantation with the AcrySof® Toric intraocular lens
Intervention Type
Device
Intervention Name(s)
AcrySof® Toric intraocular lens
Intervention Description
Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery
Primary Outcome Measure Information:
Title
Rotational Stability
Description
Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.
Time Frame
6 Months post-surgery
Secondary Outcome Measure Information:
Title
Residual Refractive Cylinder
Description
The refractive astigmatism 6 months post-surgery, measured in diopters.
Time Frame
6 Months post-surgery
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:
Monolateral or bilateral cataracts
anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D
0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
able to sign the informed consent, to comply with scheduled visits and other study procedures
Exclusion Criteria:
Preoperative ocular pathology
previous intraocular or corneal surgery
an increased risk for complications which could require vitreoretinal surgery
corneal irregularities
corneal opacities
current contact lens usage
uncontrolled diabetes
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
Rotational Stability of the AcrySof® Toric
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