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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01299155
First received: February 17, 2011
Last updated: October 22, 2012
Last verified: October 2011
History of Changes
  Purpose

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).


Condition Intervention
Cataract
 Device: ReSTOR +3
Device: LENTIS MPlus

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Unilateral Uncorrected Near Visual Acuity [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299155

Locations
Spain
Contact Alcon Call Center for Trial Locations
Oviedo, Asturias, Spain, 33012
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01299155     History of Changes
Other Study ID Numbers: M10-070
Study First Received: February 17, 2011
Last Updated: October 22, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Alcon Research:
Intraocular Lens
Presbyopia Correcting IOL

Additional relevant MeSH terms:
Presbyopia
Cataract
Refractive Errors
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on May 19, 2013