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Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

NCT ID: NCT00759096

Last Updated: 2023-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.

Detailed Description

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Conditions

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Visual Acuity

Keywords

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bilateral implantation ReSTOR Aspheric IOL uniocular unaided distance binocular unaided distance intermediate visual acuity near visual acuity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acrysof ReSTOR IOL

AcrySof ReSTOR Intraocular lens (IOL) implanted

Group Type EXPERIMENTAL

RESTOR IOL Model SA60D3

Intervention Type DEVICE

Implanted into the study eye following cataract extraction surgery

Interventions

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RESTOR IOL Model SA60D3

Implanted into the study eye following cataract extraction surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ≥21 years of either gender or any race
* Potential post-op VA 20/20
* Pre-op astigmatism ≤ 1.0D
* Able to sign the informed consent
* Able to complete all required postoperative visits
* Planned cataract removal by phaco
* Clear intraocular media other than cataract

Exclusion Criteria

* Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
* Any corneal pathology and previous corneal refractive surgery
* Patients with unrealistic expectations in anticipated post-op VA
* Happy to wear glasses
* Occupational night driver
Minimum Eligible Age

21 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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MS-06-03

Identifier Type: -

Identifier Source: org_study_id