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OpenTrials
Completed

NCT Number: NCT00731640

Contralateral ReSTOR / Monofocal or Phakic Eye

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

Completed

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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

  • Unilateral operable cataract
  • Candidate for presbyopic intraocular lens (IOL)

Exclusion criteria

  • Ocular comorbidities compromising primary outcome
  • Bilateral cataracts

Treatment and study plan

ReSTOR

Device

AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted

Primary outcomes

  1. Visual Acuity

    Time frame: 6 months

    Uncorrected 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.

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 (log) 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. Patient Satisfaction

    Time frame: 6 Months Postoperative

    Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).

  3. Spectacle Independence

    Time frame: 6 Months

    The percentage of patients reporting spectacle independence (no longer needing to wear glasses).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye

Important dates

Study start
2007
Primary completion
2008
First posted
Aug 11, 2008
Registry last updated
Mar 23, 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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