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

NCT ID: NCT00760058

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AcrySof® IQ intraocular lens

Group Type EXPERIMENTAL

AcrySof® IQ IOL

Intervention Type DEVICE

Replacement of natural crystalline lens in cataract surgery

2

Tecnis® Aspheric intraocular lens

Group Type ACTIVE_COMPARATOR

Tecnis® Aspheric intraocular lens

Intervention Type DEVICE

Replacement of natural crystalline lens in cataract surgery

3

Akreos® MI60 intraocular lens

Group Type ACTIVE_COMPARATOR

Akreos® MI60 intraocular lens

Intervention Type DEVICE

Replacement of natural crystalline lens in cataract surgery

Interventions

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AcrySof® IQ IOL

Replacement of natural crystalline lens in cataract surgery

Intervention Type DEVICE

Tecnis® Aspheric intraocular lens

Replacement of natural crystalline lens in cataract surgery

Intervention Type DEVICE

Akreos® MI60 intraocular lens

Replacement of natural crystalline lens in cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Alcon Laboratories (Australia) Pty Ltd

Locations

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Alcon Call Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AUS-06-02

Identifier Type: -

Identifier Source: org_study_id

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