Back to resultsInvestigation of Corneal Aberrations and Visual Outcomes in Patients Implanted With an AcrySof Toric Intraocular Lens (IOL)
Primary Purpose
Cataracts, Astigmatism
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Toric
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts focused on measuring Cataract, Toric IOL, Corneal Aberration, Astigmatism, AcrySof
Eligibility Criteria
Inclusion Criteria:
- Operable cataracts;
- Good ocular health;
- Qualifies for AcrySof Toric IOL via AcrySof Toric Calculator (1.03-2.06 D cylinder at corneal plane)
Exclusion Criteria:
- >2.06 D astigmatism at corneal plane;
- irregular astigmatism;
- prior or ongoing corneal disease or scarring;
- history of ocular disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Toric
Arm Description
AcrySof Toric IOL to assess corneal aberration
Outcomes
Primary Outcome Measures
Corneal Aberration
Secondary Outcome Measures
Visual acuity, residual refractive cylinder, lens alignment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00878839
Brief Title
Investigation of Corneal Aberrations and Visual Outcomes in Patients Implanted With an AcrySof Toric Intraocular Lens (IOL)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Product availability
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (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
A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g. visual acuity) in patients implanted with an AcrySof Toric IOL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts, Astigmatism
Keywords
Cataract, Toric IOL, Corneal Aberration, Astigmatism, AcrySof
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toric
Arm Type
Other
Arm Description
AcrySof Toric IOL to assess corneal aberration
Intervention Type
Device
Intervention Name(s)
Toric
Intervention Description
AcrySof Toric IOL
Primary Outcome Measure Information:
Title
Corneal Aberration
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual acuity, residual refractive cylinder, lens alignment
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Operable cataracts;
Good ocular health;
Qualifies for AcrySof Toric IOL via AcrySof Toric Calculator (1.03-2.06 D cylinder at corneal plane)
Exclusion Criteria:
>2.06 D astigmatism at corneal plane;
irregular astigmatism;
prior or ongoing corneal disease or scarring;
history of ocular disease
12. IPD Sharing Statement
Learn more about this trial
Investigation of Corneal Aberrations and Visual Outcomes in Patients Implanted With an AcrySof Toric Intraocular Lens (IOL)
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