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Visual Function After Implantation of AcrySof® Toric Lens

NCT ID: NCT01074606

Last Updated: 2012-09-19

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) 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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Toric

AcrySof Toric Intraocular Lens (IOL)

Group Type EXPERIMENTAL

AcrySof Toric Intraocular Lens

Intervention Type DEVICE

Implantation of the AcrySof Toric Intraocular Lens (IOL)

Interventions

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AcrySof Toric Intraocular Lens

Implantation of the AcrySof Toric Intraocular Lens (IOL)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
* Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
* All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
* For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.

Exclusion Criteria

* Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
* AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.
Minimum Eligible Age

20 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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Changhua, , Taiwan

Site Status

Countries

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United States Taiwan

Other Identifiers

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MT-0902

Identifier Type: -

Identifier Source: org_study_id