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Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

This study has been withdrawn prior to enrollment.
(Enrollment not initiated for study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760058
First Posted: September 25, 2008
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
September 24, 2008
September 25, 2008
May 12, 2015
June 2008
December 2010   (Final data collection date for primary outcome measure)
Contrast sensitivity [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00760058 on ClinicalTrials.gov Archive Site
Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction. [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cataract
  • Device: AcrySof® IQ IOL
    Replacement of natural crystalline lens in cataract surgery
  • Device: Tecnis® Aspheric intraocular lens
    Replacement of natural crystalline lens in cataract surgery
  • Device: Akreos® MI60 intraocular lens
    Replacement of natural crystalline lens in cataract surgery
  • Experimental: 1
    AcrySof® IQ intraocular lens
    Intervention: Device: AcrySof® IQ IOL
  • Active Comparator: 2
    Tecnis® Aspheric intraocular lens
    Intervention: Device: Tecnis® Aspheric intraocular lens
  • Active Comparator: 3
    Akreos® MI60 intraocular lens
    Intervention: Device: Akreos® MI60 intraocular lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects, aged 50 and over.
  • Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
  • Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
  • Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
  • Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.

Exclusion Criteria:

  • Subjects who have previously had corneal surgery.
  • Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology
  • Subjects with corneal pathology.
  • Subjects with astigmatism of greater than 1D.
  • Subjects diagnosed with glaucoma.
  • Subjects diagnosed with diabetes.
  • Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
  • Subjects with a know history of poor compliance
  • Subjects with planned adjunctive surgery
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00760058
AUS-06-02
No
Not Provided
Not Provided
Robert Kitchen, Director of Scientific Affairs, Alcon Laboratories (Australia) Pty Ltd
Alcon Research
Not Provided
Not Provided
Alcon Research
March 2010

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