Expired Study
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Fort Worth, Texas 76134


Purpose:

This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL


Criteria:

Inclusion Criteria: - Diagnosed with cataracts Exclusion Criteria: - Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings


Study is Available At:


Original ID:

M07-002


NCT ID:

NCT00721253


Secondary ID:


Study Acronym:


Brief Title:

Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA


Official Title:

Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alcon Research


Oversight Authority:

Spain: Ministry of Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

42


Enrollment Type:

Actual


Study Dates

Start Date:July 2007
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:October 2008
Primary Completion Type:Actual
Verification Date:March 2010
Last Changed Date:March 4, 2010
First Received Date:July 21, 2008
First Results Date:September 18, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Defocus Curve
Time Frame:6 months post-operative
Safety Issues:False
Description:Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indic
Outcome Type:Secondary Outcome
Measure:Contrast Sensitivity
Time Frame:6 months
Safety Issues:False
Description:Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the
Outcome Type:Primary Outcome
Measure:Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
Time Frame:6 months
Safety Issues:False
Description:Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.

Study Interventions

Intervention Type:Device
Name:ReSTOR
Description:Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)
Arm Name:ReSTOR Aspheric +4
Intervention Type:Device
Name:Tecnis
Description:Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)
Arm Name:Tecnis MF
Intervention Type:Device
Name:Acri.LISA
Description:Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)
Arm Name:Acri.LISA

Study Arms

Study Arm Type:Active Comparator
Arm Name:Acri.LISA
Description:Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
Study Arm Type:Active Comparator
Arm Name:Tecnis MF
Description:Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
Study Arm Type:Active Comparator
Arm Name:ReSTOR Aspheric +4
Description:ACRYSOF ReSTOR Aspheric +4 Model SN6AD3

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Alcon Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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