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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

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01279031
First received: January 14, 2011
Last updated: January 13, 2012
Last verified: January 2012

January 14, 2011
January 13, 2012
October 2011
January 2012   (final data collection date for primary outcome measure)
Visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01279031 on ClinicalTrials.gov Archive Site
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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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cataracts
  • Astigmatism
  • Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
    Comparison of vision after cataract surgery based on two different types of equipment.
  • Device: Alcon Infiniti wiht the OZIL Torsional Handpiece
    Comparision of vision after cataract surgery based on two different types of equipment.
  • Experimental: Abbott WHITESTAR Signature System
    Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
    Intervention: Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
  • Experimental: Alcon Infiniti
    Alcon Infiniti with the OZIL Torsional Handpiece
    Intervention: Device: Alcon Infiniti wiht the OZIL Torsional Handpiece
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01279031
Abbott2010-Whitestar
No
Melissa Earl, CRO
Innovative Medical
Not Provided
Not Provided
Innovative Medical
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP