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Surgeon Experience ReSTOR A +4 Intraocular Lens (IOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733512
First Posted: August 13, 2008
Last Update Posted: March 27, 2017
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.
Information provided by (Responsible Party):
Alcon Research
  Purpose
To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.

Condition Intervention
Cataract Device: ReSTOR

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:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 1 week to 10 months ]
    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 ]
    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
Study Completion Date: March 2008
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00733512


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00733512     History of Changes
Other Study ID Numbers: M07-019
First Submitted: August 8, 2008
First Posted: August 13, 2008
Results First Submitted: March 24, 2010
Results First Posted: April 15, 2010
Last Update Posted: March 27, 2017
Last Verified: April 2010

Keywords provided by Alcon Research:
ReSTOR Aspheric +4 IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases