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Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

NCT ID: NCT00720005

Last Updated: 2010-10-04

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal

Detailed Description

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The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.

Conditions

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Cataract

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Aspheric Acrysof ResTOR Lens

Implantation of Aspheric Acrysof ResTOR

Aspheric Acrysof ReSTOR intraocular lens

Intervention Type DEVICE

Bilateral implantation of Aspheric Acrysof ReSTOR

Interventions

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Aspheric Acrysof ReSTOR intraocular lens

Bilateral implantation of Aspheric Acrysof ReSTOR

Intervention Type DEVICE

Other Intervention Names

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Acrysof ReSTOR

Eligibility Criteria

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Inclusion Criteria

* Subject must have an age-related cataract in both eyes.
* 40 years of age or older.
* Patient must desire cataract extraction.
* Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
* Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria

* Preoperative ocular pathology potentially affecting visual acuity.
* Keratometric astigmatism exceeding 1.50 diopters.
* Planned postoperative refraction for mono-vision.
* Uncontrolled diabetes.
* Use of any systemic or topical drug known to interfere with visual performance.
* Contact lens use during the active treatment portion of the trial.
* Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
* Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
* Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
* Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
* Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
* Other ocular surgery at the time of the cataract extraction.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Storm Eye Institute - Medical University of South Carolina

Principal Investigators

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Kerry D. Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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MRC-07-002

Identifier Type: -

Identifier Source: org_study_id