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This study has been withdrawn prior to enrollment.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. )

First Received on September 24, 2008. Last Updated on March 3, 2010 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00760058

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 IV

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:

MedlinePlus related topics: Cataract

U.S. FDA Resources

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 February 09, 2012