Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses

NCT ID: NCT00876707

Last Updated: 2010-07-02

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

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.

Detailed Description

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Conditions

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Cataract Astigmatism

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tecnis

Group Type ACTIVE_COMPARATOR

Tecnis implant

Intervention Type DEVICE

Implant of diffractive multifocal IOL Tecnis

ReSTOR

Group Type ACTIVE_COMPARATOR

ReSTOR implant

Intervention Type DEVICE

Implant of multifocal IOL ReSTOR

ReZoom

Group Type ACTIVE_COMPARATOR

ReZoom implant

Intervention Type DEVICE

Implant of multifocal IOL ReZoom

Interventions

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Tecnis implant

Implant of diffractive multifocal IOL Tecnis

Intervention Type DEVICE

ReSTOR implant

Implant of multifocal IOL ReSTOR

Intervention Type DEVICE

ReZoom implant

Implant of multifocal IOL ReZoom

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D

Exclusion Criteria

* Any ocular diseases, such as:

* corneal opacities or irregularity
* dry eye
* amblyopia
* anisometropia
* glaucoma
* retinal abnormality
* Surgical complications
* IOL tilt
* IOL decentration greater than 0.4 mm (estimated by retroillumination)
* Incomplete follow-up
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of São Paulo

Locations

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University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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0088/09

Identifier Type: -

Identifier Source: org_study_id

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