Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA

NCT ID: NCT00721253

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-10-31

Brief Summary

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This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

Detailed Description

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Conditions

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Cataract

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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ReSTOR Aspheric +4

ACRYSOF ReSTOR Aspheric +4 Model SN6AD3

Group Type ACTIVE_COMPARATOR

ReSTOR

Intervention Type DEVICE

Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)

Tecnis MF

Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900

Group Type ACTIVE_COMPARATOR

Tecnis

Intervention Type DEVICE

Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)

Acri.LISA

Meditec Acri.LISA Intraocular Lens (IOL) Model 366D

Group Type ACTIVE_COMPARATOR

Acri.LISA

Intervention Type DEVICE

Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)

Interventions

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ReSTOR

Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)

Intervention Type DEVICE

Tecnis

Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)

Intervention Type DEVICE

Acri.LISA

Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with cataracts

Exclusion Criteria

* Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings
Minimum Eligible Age

18 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

Locations

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Contact 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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M07-002

Identifier Type: -

Identifier Source: org_study_id

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