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A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

NCT ID: NCT01166971

Last Updated: 2011-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

Detailed Description

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Conditions

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Cataract

Keywords

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presbyopia intraocular lens

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ReSTOR +3

Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction

Group Type EXPERIMENTAL

ReSTOR +3

Intervention Type DEVICE

Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction

Tecnis MF

Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction

Group Type ACTIVE_COMPARATOR

Tecnis MF

Intervention Type DEVICE

Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

Interventions

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ReSTOR +3

Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction

Intervention Type DEVICE

Tecnis MF

Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diagnosed with bilateral cataracts
* candidate for presbyopic lens

Exclusion Criteria

* \>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
* pre-existing conditions that could skew the results
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

Locations

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The Eye Center of North Florida

Panama City, Florida, United States

Site Status

Carolina Eye Care Physicians

Charleston, South Carolina, United States

Site Status

Whitsett Vision Group

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M09-050

Identifier Type: -

Identifier Source: org_study_id