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Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

Primary Purpose

Cataract

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3
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 IOL ReSTOR Aspheric, Bilateral cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

  • Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
  • All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Sites / Locations

  • Dr John Blaylock
  • Dr Dominique Meyer

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ReSTOR

Arm Description

Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.

Outcomes

Primary Outcome Measures

Binocular Visual Acuity at Near, Intermediate and Distance
Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2008
Last Updated
November 21, 2011
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00710905
Brief Title
Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
Official Title
Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Postmarket study terminated as the SN6AD3 is no longer promoted.
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract IOL ReSTOR Aspheric, Bilateral cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReSTOR
Arm Type
Experimental
Arm Description
Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Intervention Type
Device
Intervention Name(s)
AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3
Intervention Description
Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye following cataract removal.
Primary Outcome Measure Information:
Title
Binocular Visual Acuity at Near, Intermediate and Distance
Description
Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits. Exclusion Criteria: Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study. All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Blaylock
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr John Blaylock
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 5A1
Country
Canada
Facility Name
Dr Dominique Meyer
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 1X6
Country
Canada

12. IPD Sharing Statement

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Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

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