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A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

NCT ID: NCT01225926

Last Updated: 2013-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.

Detailed Description

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Conditions

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Cataract

Keywords

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Intraocular Lens Toric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Toric T3 - T9

AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.

Group Type EXPERIMENTAL

Toric T3 - T9

Intervention Type DEVICE

Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient

IQ SN60WF

AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.

Group Type ACTIVE_COMPARATOR

IQ SN60WF

Intervention Type DEVICE

Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient

Interventions

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Toric T3 - T9

Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient

Intervention Type DEVICE

IQ SN60WF

Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient

Intervention Type DEVICE

Other Intervention Names

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AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9 AcrySof® IQ IOL Model SN60WF

Eligibility Criteria

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Inclusion Criteria

* Willing and able to understand and sign an informed consent;
* Willing and able to attend post-operative examinations per protocol schedule;
* In good ocular health, with the exception of cataracts;
* Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
* Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
* In good ocular health, with the exception of cataracts;
* Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;

Exclusion Criteria

* Previous corneal surgery;
* Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Ocular disease and/or condition that may compromise study results;
* Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
* Pregnant or planning pregnancy during course of study;
* Participation in any other investigational study within 30 days prior to enrolment;
Minimum Eligible Age

21 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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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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M10-003

Identifier Type: -

Identifier Source: org_study_id