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Contralateral ReSTOR / Monofocal or Phakic Eye

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00731640
First received: August 7, 2008
Last updated: March 19, 2010
Last verified: March 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Cataracts
 Device: ReSTOR
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Contrast Sensitivity [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction [ Time Frame: 6 Months Postoperative ] [ Designated as safety issue: No ]
    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).

  • Spectacle Independence [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    The percentage of patients reporting spectacle independence (no longer needing to wear glasses).


Enrollment: 52
Study Start Date: June 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731640

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

No publications provided

Responsible Party: Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier: NCT00731640     History of Changes
Other Study ID Numbers: M07-012
Study First Received: August 7, 2008
Results First Received: September 9, 2009
Last Updated: March 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
AcrySof
ReSTOR
Multifocal
Intraocular Lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013