Back to resultsRandomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial
Primary Purpose
Cataracts, Astigmatism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Alcon Infiniti wiht the OZIL Torsional Handpiece
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts
Eligibility Criteria
Inclusion Criteria:
- Patients at least 21 scheduled to undergo bilateral phacoemulsification with implantation of multifocal IOLs.
- Both eyes must have similar degrees of cataract and astigmatism (topographic cylinder difference of <2.00D as well as similar globe axial length as measured by the IOL Master of <0.5mm).
- Visual potential of UCVA 20/25/ or better.
- Clear intraocular media other than cataract.
Exclusion Criteria:
- Clinically relevant differences between eyes in ocular disease or pathology.
- Presence of glaucoma, macular disease, or foveal disease to an asymmetrical degree.
- Asymmetrical use of ocular medications.
Sites / Locations
- Kerry Assil
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Abbott WHITESTAR Signature System
Alcon Infiniti
Arm Description
Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Alcon Infiniti with the OZIL Torsional Handpiece
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01279031
Brief Title
Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial
Official Title
Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Innovative Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to look at the outcomes of your vision after your cataract surgery based on two different types of equipment that will be used during your surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Abbott WHITESTAR Signature System
Arm Type
Experimental
Arm Description
Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Arm Title
Alcon Infiniti
Arm Type
Experimental
Arm Description
Alcon Infiniti with the OZIL Torsional Handpiece
Intervention Type
Device
Intervention Name(s)
Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Intervention Description
Comparison of vision after cataract surgery based on two different types of equipment.
Intervention Type
Device
Intervention Name(s)
Alcon Infiniti wiht the OZIL Torsional Handpiece
Intervention Description
Comparision of vision after cataract surgery based on two different types of equipment.
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients at least 21 scheduled to undergo bilateral phacoemulsification with implantation of multifocal IOLs.
Both eyes must have similar degrees of cataract and astigmatism (topographic cylinder difference of <2.00D as well as similar globe axial length as measured by the IOL Master of <0.5mm).
Visual potential of UCVA 20/25/ or better.
Clear intraocular media other than cataract.
Exclusion Criteria:
Clinically relevant differences between eyes in ocular disease or pathology.
Presence of glaucoma, macular disease, or foveal disease to an asymmetrical degree.
Asymmetrical use of ocular medications.
Facility Information:
Facility Name
Kerry Assil
City
Beverly Hills
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial
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