Safety and Effectiveness of the Akreos Toric Intraocular Lens.

NCT ID: NCT00825513

Last Updated: 2013-03-25

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.

Detailed Description

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Conditions

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Cataract Astigmatism

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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Akreos Toric

Akreos Toric Intraocular Lens

Group Type EXPERIMENTAL

Akreos Toric IOL

Intervention Type DEVICE

Lens implant following cataract surgery

Akreos Advanced

Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Group Type ACTIVE_COMPARATOR

Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Intervention Type DEVICE

Lens implant following cataract surgery

Interventions

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Akreos Toric IOL

Lens implant following cataract surgery

Intervention Type DEVICE

Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Lens implant following cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
* Subjects must require a lens power from 15 to 30 diopters.

Exclusion Criteria

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Subjects with corneal pathology potentially affecting topography.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriele Brenger

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital

Umeå, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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566

Identifier Type: -

Identifier Source: org_study_id

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