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
  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:


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
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, see Learn About Clinical Studies.

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 July 20, 2014