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This study has been withdrawn prior to enrollment.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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 24, 2008
Last Updated Date	March 3, 2010
Start Date ^ICMJE	June 2008
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 24, 2008)	Contrast sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00760058 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 24, 2008)	Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
Official Title ^ICMJE	Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cataract
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	75
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00760058
Other Study ID Numbers ^ICMJE	AUS-06-02
Has Data Monitoring Committee	No
Responsible Party	Robert Kitchen, Director of Scientific Affairs, Alcon Laboratories (Australia) Pty Ltd
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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