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

Primary Purpose

Cataract

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

ReSTOR +3

LENTIS MPlus

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, Presbyopia Correcting IOL

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ReSTOR +3

LENTIS MPlus

Arm Description

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

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

Outcomes

Primary Outcome Measures

Unilateral Uncorrected Near Visual Acuity

Secondary Outcome Measures

Full Information

NCT ID

NCT01299155

First Posted

February 17, 2011

Last Updated

October 22, 2012

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01299155

Brief Title

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

Official Title

A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

Intraocular Lens, Presbyopia Correcting IOL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ReSTOR +3

Arm Type

Experimental

Arm Description

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

Arm Title

LENTIS MPlus

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

ReSTOR +3

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

LENTIS MPlus

Intervention Description

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

Primary Outcome Measure Information:

Title

Unilateral Uncorrected Near Visual Acuity

Time Frame

3 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Contact Alcon Call Center for Trial Locations

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33012

Country

Spain

12. IPD Sharing Statement

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

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