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Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00719732
First received: July 21, 2008
Last updated: March 4, 2010
Last verified: March 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Cataract
 Device: ReSTOR
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Uncorrected Visual Acuity (UCVA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 218
Study Start Date: September 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719732

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: Diane Houtman, Alcon Research, Ltd.
ClinicalTrials.gov Identifier: NCT00719732     History of Changes
Obsolete Identifiers: NCT00762203
Other Study ID Numbers: M07-001
Study First Received: July 21, 2008
Results First Received: September 18, 2009
Last Updated: March 4, 2010
Health Authority: Spain: Ministry of Health

Keywords provided by Alcon Research:
ReSTOR Aspheric +3 IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013