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OpenTrials
Completed

NCT Number: NCT00733512

Surgeon Experience ReSTOR A +4 Intraocular Lens (IOL)

To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • operable cataracts; candidate for presbyopic correcting intraocular lens (IOL)

Exclusion criteria

  • ocular comorbidities confounding study outcomes

Treatment and study plan

ReSTOR

Device

Patients were implanted with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) in one or both eyes for treatment of cataract.

Primary outcomes

  1. Visual Acuity

    Time frame: 1 week to 10 months

    Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by 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: 1 week to 10 months

    Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Surgeon Experience ReSTOR Aspheric +4 Intraocular Lens (IOL)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2008
Registry last updated
Mar 27, 2017

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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