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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This study has been withdrawn prior to enrollment.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:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 25, 2014