Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

NCT ID: NCT00719732

Last Updated: 2010-03-16

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

PHASE4

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-05-31

Brief Summary

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A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).

Detailed Description

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Conditions

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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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ReSTOR Aspheric +3

Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).

Group Type EXPERIMENTAL

ReSTOR

Intervention Type DEVICE

Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).

Interventions

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ReSTOR

Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with cataracts

Exclusion Criteria

* Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;
* \<1 diopter astigmatism by keratometry readings.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Alcon Research, Ltd.

Locations

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Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M07-001

Identifier Type: -

Identifier Source: org_study_id

NCT00762203

Identifier Type: -

Identifier Source: nct_alias

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