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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01299155
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : October 23, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE February 17, 2011
First Posted Date  ICMJE February 18, 2011
Last Update Posted Date October 23, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
Unilateral Uncorrected Near Visual Acuity [ Time Frame: 3 months after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses
Official Title  ICMJE A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Device: ReSTOR +3
    Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.
  • Device: LENTIS MPlus
    Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.
Study Arms  ICMJE
  • Experimental: ReSTOR +3
    Bilateral implantation of a ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1
    Intervention: Device: ReSTOR +3
  • Active Comparator: LENTIS MPlus
    Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) Model
    Intervention: Device: LENTIS MPlus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2012)
24
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2011)
20
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01299155
Other Study ID Numbers  ICMJE M10-070
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP