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ReSTOR Natural +3.0D Study In Japan

NCT ID: NCT00758576

Last Updated: 2010-12-21

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

Brief Summary

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The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.

Detailed Description

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Conditions

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Cataract

Keywords

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SN6AD1

AcrySof ReSTOR Model SN6AD1 Intraocular Lens

Group Type EXPERIMENTAL

ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1

Intervention Type DEVICE

Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.

Interventions

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ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1

Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Planned bilateral cataract removal by phacoemulsification
* Potential postoperative best corrected visual acuity of 0.5 or over
* 1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry

Exclusion Criteria

* Poorly controlled glaucoma
* Progressive diabetic retinopathy
Minimum Eligible Age

20 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

Locations

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Hayashi Eye Hospital

Fukuoka, Fukuoka, Japan

Site Status

Countries

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Japan

Other Identifiers

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C-07-44

Identifier Type: -

Identifier Source: org_study_id