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Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

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ClinicalTrials.gov Identifier: NCT00719732
Recruitment Status : Completed
First Posted : July 22, 2008
Results First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Study Start Date : September 2007
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ReSTOR Aspheric +3
Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Device: ReSTOR
Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).


Outcome Measures

Primary Outcome Measures :
  1. Uncorrected Visual Acuity (UCVA) [ Time Frame: 6 months ]
    Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with cataracts

Exclusion Criteria:

  • Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;
  • <1 diopter astigmatism by keratometry readings.
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): NCT00719732


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: Diane Houtman, Alcon Research, Ltd.
ClinicalTrials.gov Identifier: NCT00719732     History of Changes
Obsolete Identifiers: NCT00762203
Other Study ID Numbers: M07-001
First Posted: July 22, 2008    Key Record Dates
Results First Posted: March 16, 2010
Last Update Posted: March 16, 2010
Last Verified: March 2010

Keywords provided by Alcon Research:
ReSTOR Aspheric +3 IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases