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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014