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OpenTrials
Completed

NCT Number: NCT00721253

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with cataracts

Exclusion criteria

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

Treatment and study plan

ReSTOR

Device

Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)

Tecnis

Device

Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)

Acri.LISA

Device

Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)

Primary outcomes

  1. Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate

    Time frame: 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 outcomes

  1. Contrast Sensitivity

    Time frame: 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.

  2. Defocus Curve

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 24, 2008
Registry last updated
Mar 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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