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Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

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ClinicalTrials.gov Identifier: NCT00710931
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : November 8, 2011
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).

Condition or disease Intervention/treatment Phase
Cataract Device: AcrySof ReSTOR Aspheric IOL model SN6AD1 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Study Start Date : October 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: ReSTOR +3 Multifocal Lens
Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
 Device: AcrySof ReSTOR Aspheric IOL model SN6AD1
Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) following cataract removal.


Outcome Measures
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Primary Outcome Measures :
  1. Binocular Visual Acuity at Distance, Near and Intermediate [ Time Frame: 6 months after surgery ]
    Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

  • Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.

All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Contacts and Locations
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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): NCT00710931


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00710931    
Other Study ID Numbers: ALCONsur001.08
First Posted: July 8, 2008    Key Record Dates
Results First Posted: November 8, 2011
Last Update Posted: December 12, 2011
Last Verified: December 2011
Keywords provided by Alcon Research:
Bilateral Cataract
IOL
ReSTOR
Aspheric
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases