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Rotational Stability of the AcrySof® Toric

NCT ID: NCT00762216

Last Updated: 2012-10-31

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

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Detailed Description

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Conditions

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Cataract

Keywords

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Toric

Implantation with the AcrySof® Toric intraocular lens

Group Type OTHER

AcrySof® Toric intraocular lens

Intervention Type DEVICE

Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery

Interventions

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AcrySof® Toric intraocular lens

Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Monolateral or bilateral cataracts
* anticipated intraocular lens (IOL) power of +10 Diopters (D) \~ +25D
* 0.75 \~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
* able to sign the informed consent, to comply with scheduled visits and other study procedures

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
* uncontrolled diabetes
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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Responsibility Role SPONSOR

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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RM-08-001

Identifier Type: -

Identifier Source: org_study_id