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Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

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ClinicalTrials.gov Identifier: NCT00818116
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : July 30, 2010
Last Update Posted : July 30, 2010
Sponsor:
Information provided by:
Alcon Research

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

Condition or disease Intervention/treatment Phase
Cataracts Device: AcrySof ReSTOR Aspheric IOL Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 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 Intraocular Lens (IOL): Postmarket Evaluation
Study Start Date : December 2008
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Uncorrected and Best Corrected Visual Acuities (Near and Distance) [ Time Frame: 6 Months Following Cataract Surgery ]
    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.



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT00818116


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

Responsible Party: China: Ethics Committee, Alcon China
ClinicalTrials.gov Identifier: NCT00818116     History of Changes
Other Study ID Numbers: CH-08-001
First Posted: January 7, 2009    Key Record Dates
Results First Posted: July 30, 2010
Last Update Posted: July 30, 2010
Last Verified: June 2010

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases