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Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

NCT ID: NCT00818116

Last Updated: 2010-07-30

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Detailed Description

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Conditions

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Cataracts

Keywords

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Cataract visual acuity AcrySof ReSTOR Aspheric Intraoculare Lens Bilateral 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 IOL

Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)

Group Type EXPERIMENTAL

AcrySof ReSTOR Aspheric IOL

Intervention Type DEVICE

Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.

Interventions

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AcrySof ReSTOR Aspheric IOL

Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
* 50\~75 years of age
* \<1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.

Exclusion Criteria

* Patients with pre-existing conditions that could skew the results.
* Any of conditions before and during surgery specified in the product information.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 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 China

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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CH-08-001

Identifier Type: -

Identifier Source: org_study_id