Visual Function After Bilateral Implantation of AcrySof® Toric

NCT ID: NCT00758550

Last Updated: 2010-03-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.

Detailed Description

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Conditions

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Visual Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AcrySof Natural IOL

AcrySof Natural Intraocular Lens (IOL)

Group Type ACTIVE_COMPARATOR

AcrySof Natural

Intervention Type DEVICE

AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

AcrySof Toric IOL

AcrySof Toric Intraocular Lens (IOL)

Group Type EXPERIMENTAL

AcrySof® Toric IOL

Intervention Type DEVICE

AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

Interventions

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AcrySof® Toric IOL

AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

Intervention Type DEVICE

AcrySof Natural

AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Bilateral cataracts
* 40\~80 years of age
* 4 Days - 1 Week interval between a single patient's surgery
* dilated pupil size (in dim light) ≥ 4.0 mm
* Anticipated correction with an IOL of +10 Diopters \~ +25 Diopters
* 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

Exclusion Criteria

* Preoperative ocular pathology
* Previous intraocular or corneal surgery
* An increased risk for complications which could require vitreoretinal surgery
* Corneal irregularities
* Corneal opacities
* Current contact lens usage(within 6 months prior to first surgery)
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 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 Research Ltd.

Locations

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Alcon Call Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CM-06-17

Identifier Type: -

Identifier Source: org_study_id

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