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Surgeon Experience ReSTOR A +4 Intraocular Lens (IOL)

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00733512
First received: August 8, 2008
Last updated: April 14, 2010
Last verified: April 2010
History of Changes
  Purpose

To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.


Condition Intervention Phase
Cataract
 Device: ReSTOR
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Surgeon Experience ReSTOR Aspheric +4 Intraocular Lens (IOL)

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: 1 week to 10 months ] [ Designated as safety issue: No ]
    Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.


Secondary Outcome Measures:
  • Contrast Sensitivity [ Time Frame: 1 week to 10 months ] [ Designated as safety issue: No ]
    Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.


Enrollment: 146
Study Start Date: June 2007
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ReSTOR
AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
 Device: ReSTOR
Patients were implanted with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) in one or both eyes for treatment of cataract.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects were selected from primary care clinics.

Criteria

Inclusion Criteria:

  • operable cataracts; candidate for presbyopic correcting intraocular lens (IOL)

Exclusion Criteria:

  • ocular comorbidities confounding study outcomes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733512

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 Dept, Alcon Research
ClinicalTrials.gov Identifier: NCT00733512     History of Changes
Other Study ID Numbers: M07-019
Study First Received: August 8, 2008
Results First Received: March 24, 2010
Last Updated: April 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
ReSTOR Aspheric +4 IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013