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A Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses

NCT ID: NCT01299155

Last Updated: 2012-10-23

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

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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To prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with LENTIS MPlus Intraocular Lens (IOL).

Detailed Description

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Conditions

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Cataract

Keywords

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Intraocular Lens Presbyopia Correcting IOL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ReSTOR +3

Bilateral implantation of a ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1

Group Type EXPERIMENTAL

ReSTOR +3

Intervention Type DEVICE

Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.

LENTIS MPlus

Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) Model

Group Type ACTIVE_COMPARATOR

LENTIS MPlus

Intervention Type DEVICE

Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.

Interventions

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ReSTOR +3

Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.

Intervention Type DEVICE

LENTIS MPlus

Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* are willing and able to understand and sign an informed consent
* \<= 1.0 Diopters of regular corneal astigmatism in both eyes. NOTE: look for consistency between manual keratometry, auto-keratometry and simulated keratometry measures to ensure "regular" astigmatism prior to enrollment. Subjects who wear contact lenses must discontinue its use for at least 2 weeks (soft contact lens) and at least 3 weeks (gas permeable contact lens) and until corneal topography shows stability prior to preoperative study measurements.
* are willing and able to attend postoperative examinations per protocol schedule
* are more than 21 years of age, of either gender and any race:
* require bilateral cataract extraction followed by posterior intraocular lens (IOL) implantation used as on-label procedure
* be willing to have second eye surgery within one month of first eye surgery
* are in good ocular health, with the exception of cataracts
* are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof IQ ReSTOR +3 and LENTIS Mplus package inserts
* are able to read and understand one of the following languages: Dutch or Spanish

Exclusion Criteria

* Planned multiple procedures, including limbal relaxing incision (LRI), during cataract/IOL implantation surgery
* An ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, macular degeneration, amblyopia, pupil abnormality such as corectopia, etc.)
* Previous corneal surgery and/or reshaping
* Clinically significant corneal endothelial dystrophy (e.g. Fuchs' dystrophy)
* History of corneal disease (eg. herpes simplex, herpes zoster keratitis, etc.)
* History of retinal detachment
* Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (eg, immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness).
* suturing of incision required at time of surgery
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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Contact Alcon Call Center for Trial Locations

Oviedo, Principality of Asturias, Spain

Site Status

Countries

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United States Spain

Other Identifiers

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M10-070

Identifier Type: -

Identifier Source: org_study_id