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ReSTOR Natural +3.0D Study In Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00758576
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : December 2, 2010
Last Update Posted : December 21, 2010
Sponsor:
Information provided by:
Alcon Research

Study Description
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Brief Summary:
The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.

Condition or disease Intervention/treatment Phase
Cataract Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ReSTOR Natural +3.0D (Diopter) Study In Japan
Study Start Date : February 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: SN6AD1
AcrySof ReSTOR Model SN6AD1 Intraocular Lens
 Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1
Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.


Outcome Measures
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Primary Outcome Measures :
  1. Uncorrected Intermediate Visual Acuity [ Time Frame: 1 year after surgery ]
    Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

  2. Uncorrected Distance Visual Acuity [ Time Frame: 1 year after surgery ]
    Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

  3. Uncorrected Near Visual Acuity [ Time Frame: 1 year after surgery ]
    Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned bilateral cataract removal by phacoemulsification
  • Potential postoperative best corrected visual acuity of 0.5 or over
  • 1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry

Exclusion Criteria:

  • Poorly controlled glaucoma
  • Progressive diabetic retinopathy
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): NCT00758576


Locations
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Japan
Hayashi Eye Hospital
Fukuoka, Japan, 812-0011
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Kaiko Itoh, Alcon
ClinicalTrials.gov Identifier: NCT00758576    
Other Study ID Numbers: C-07-44
First Posted: September 25, 2008    Key Record Dates
Results First Posted: December 2, 2010
Last Update Posted: December 21, 2010
Last Verified: December 2010
Keywords provided by Alcon Research:
Cataract
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases