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ReSTOR Natural +3.0D Study In Japan

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00758576
First received: September 23, 2008
Last updated: December 6, 2010
Last verified: December 2010
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: ReSTOR Natural +3.0D (Diopter) Study In Japan

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 Intermediate Visual Acuity [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758576

Locations
Japan
Hayashi Eye Hospital
Fukuoka, Japan, 812-0011
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Kaiko Itoh, Alcon
ClinicalTrials.gov Identifier: NCT00758576     History of Changes
Other Study ID Numbers: C-07-44
Study First Received: September 23, 2008
Results First Received: October 8, 2010
Last Updated: December 6, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Alcon Research:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013