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Contralateral ReSTOR / Monofocal or Phakic Eye

This study has been completed.
Information provided by:
Alcon Research Identifier:
First received: August 7, 2008
Last updated: March 19, 2010
Last verified: March 2010
Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

Condition Intervention Phase
Cataracts Device: ReSTOR Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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).

  • Spectacle Independence [ Time Frame: 6 Months ]
    The percentage of patients reporting spectacle independence (no longer needing to wear glasses).

Enrollment: 52
Study Start Date: June 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Monofocal
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye
Device: ReSTOR
AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted
Active Comparator: Phakic
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Device: ReSTOR
AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Ocular comorbidities compromising primary outcome
  • Bilateral cataracts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00731640

United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research Identifier: NCT00731640     History of Changes
Other Study ID Numbers: M07-012
Study First Received: August 7, 2008
Results First Received: September 9, 2009
Last Updated: March 19, 2010

Keywords provided by Alcon Research:
Intraocular Lens

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on August 16, 2017