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

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: ReSTOR; Device: Tecnis; Device: Acri.LISA

• Registration Number: NCT00721253
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-24
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-09-18
• Status Verified: 2010-03
• Results First Submitted QC: 2010-03-04
• Last Update Submitted: 2010-03-04
• Results First Posted: 2010-03-16
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Diagnosed with cataracts

Exclusion Criteria

• Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReSTOR Aspheric +4	ReSTOR	ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
Tecnis MF	Tecnis	Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
Acri.LISA	Acri.LISA	Meditec Acri.LISA Intraocular Lens (IOL) Model 366D

Primary Outcome Measures

Name	Time	Method
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Contrast Sensitivity	6 months	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 logarithmic units translates to better contrast sensitivity.
Defocus Curve	6 months post-operative	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 indicates better visual acuity.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States