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ReSTOR Natural +3.0D Study In Japan

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hayashi Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SN6AD1

Arm Description

AcrySof ReSTOR Model SN6AD1 Intraocular Lens

Outcomes

Primary Outcome Measures

Uncorrected Intermediate Visual Acuity
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2008
Last Updated
December 6, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00758576
Brief Title
ReSTOR Natural +3.0D Study In Japan
Official Title
ReSTOR Natural +3.0D (Diopter) Study In Japan
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SN6AD1
Arm Type
Experimental
Arm Description
AcrySof ReSTOR Model SN6AD1 Intraocular Lens
Intervention Type
Device
Intervention Name(s)
ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1
Intervention Description
Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.
Primary Outcome Measure Information:
Title
Uncorrected Intermediate Visual Acuity
Description
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.
Time Frame
1 year after surgery
Title
Uncorrected Distance Visual Acuity
Description
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.
Time Frame
1 year after surgery
Title
Uncorrected Near Visual Acuity
Description
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.
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hayashi Eye Hospital
City
Fukuoka
ZIP/Postal Code
812-0011
Country
Japan

12. IPD Sharing Statement

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ReSTOR Natural +3.0D Study In Japan

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