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Contralateral ReSTOR / Monofocal or Phakic Eye

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ClinicalTrials.gov Identifier: NCT00731640
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : March 16, 2010
Last Update Posted : March 23, 2010
Sponsor:
Information provided by:
Alcon Research

Brief Summary:
Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

Condition or disease Intervention/treatment Phase
Cataracts Device: ReSTOR Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye
Study Start Date : June 2007
Actual Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Monofocal
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye
Device: ReSTOR
AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted
Active Comparator: Phakic
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Device: ReSTOR
AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted



Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 6 months ]
    Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.


Secondary Outcome Measures :
  1. Contrast Sensitivity [ Time Frame: 6 Months ]
    Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.

  2. Patient Satisfaction [ Time Frame: 6 Months Postoperative ]
    Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).

  3. Spectacle Independence [ Time Frame: 6 Months ]
    The percentage of patients reporting spectacle independence (no longer needing to wear glasses).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral operable cataract
  • Candidate for presbyopic intraocular lens (IOL)

Exclusion Criteria:

  • Ocular comorbidities compromising primary outcome
  • Bilateral cataracts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731640


Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

Responsible Party: Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier: NCT00731640     History of Changes
Other Study ID Numbers: M07-012
First Posted: August 11, 2008    Key Record Dates
Results First Posted: March 16, 2010
Last Update Posted: March 23, 2010
Last Verified: March 2010

Keywords provided by Alcon Research:
AcrySof
ReSTOR
Multifocal
Intraocular Lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases