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

October 22, 2012 updated by: Alcon Research

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Asturias
      • Oviedo, Asturias, Spain, 33012
        • Contact Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ReSTOR +3
Bilateral implantation of a ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1
Device: ReSTOR +3
Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.
Active Comparator: LENTIS MPlus
Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) Model
Device: LENTIS MPlus
Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unilateral Uncorrected Near Visual Acuity
Time Frame: 3 months after surgery
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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