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Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00818116
First received: January 6, 2009
Last updated: June 30, 2010
Last verified: June 2010
History of Changes
  Purpose

The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).


Condition Intervention Phase
Cataracts
 Device: AcrySof ReSTOR Aspheric IOL
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation

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 and Best Corrected Visual Acuities (Near and Distance) [ Time Frame: 6 Months Following Cataract Surgery ] [ Designated as safety issue: No ]
    Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. 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: 34
Study Start Date: December 2008
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReSTOR Aspheric IOL
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
 Device: AcrySof ReSTOR Aspheric IOL
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
  • 50~75 years of age
  • <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.

Exclusion Criteria:

  • Patients with pre-existing conditions that could skew the results.
  • Any of conditions before and during surgery specified in the product information.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818116

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: China: Ethics Committee, Alcon China
ClinicalTrials.gov Identifier: NCT00818116     History of Changes
Other Study ID Numbers: CH-08-001
Study First Received: January 6, 2009
Results First Received: June 30, 2010
Last Updated: June 30, 2010
Health Authority: China: Ethics Committee

Keywords provided by Alcon Research:
Cataract
visual acuity
AcrySof ReSTOR Aspheric Intraoculare Lens
Bilateral cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013