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

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ClinicalTrials.gov Identifier: NCT00760058
Recruitment Status : Withdrawn (Enrollment not initiated for study.)
First Posted : September 25, 2008
Last Update Posted : May 12, 2015
Sponsor:
Information provided by:
Alcon Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Device: AcrySof® IQ IOL Device: Tecnis® Aspheric intraocular lens Device: Akreos® MI60 intraocular lens Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
Study Start Date : June 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
AcrySof® IQ intraocular lens
Device: AcrySof® IQ IOL
Replacement of natural crystalline lens in cataract surgery
Active Comparator: 2
Tecnis® Aspheric intraocular lens
Device: Tecnis® Aspheric intraocular lens
Replacement of natural crystalline lens in cataract surgery
Active Comparator: 3
Akreos® MI60 intraocular lens
Device: Akreos® MI60 intraocular lens
Replacement of natural crystalline lens in cataract surgery



Primary Outcome Measures :
  1. Contrast sensitivity [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction. [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760058


Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

Responsible Party: Robert Kitchen, Director of Scientific Affairs, Alcon Laboratories (Australia) Pty Ltd
ClinicalTrials.gov Identifier: NCT00760058     History of Changes
Other Study ID Numbers: AUS-06-02
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: March 2010

Keywords provided by Alcon Research:
cataract, intraocular lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases