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ReSTOR Natural +3.0D Study In Japan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758576
First Posted: September 25, 2008
Last Update Posted: December 21, 2010
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.
Information provided by:
Alcon Research
  Purpose
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 Intervention
Cataract Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.


Enrollment: 64
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
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
Japan
Hayashi Eye Hospital
Fukuoka, Japan, 812-0011
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Kaiko Itoh, Alcon
ClinicalTrials.gov Identifier: NCT00758576     History of Changes
Other Study ID Numbers: C-07-44
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: October 8, 2010
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:
Cataract
Lens Diseases
Eye Diseases