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This study has been withdrawn prior to enrollment.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:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00760058
First received: September 24, 2008
Last updated: March 3, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Cataract
Device: AcrySof® IQ IOL
Device: Tecnis® Aspheric intraocular lens
Device: Akreos® MI60 intraocular lens
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Contrast sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: June 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760058

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

No publications provided

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
Study First Received: September 24, 2008
Last Updated: March 3, 2010
Health Authority: Australia:Health Research Ethics Committee

Keywords provided by Alcon Research:
cataract, intraocular lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014