Contralateral ReSTOR / Monofocal or Phakic Eye

March 19, 2010 updated by: Alcon Research

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Ocular comorbidities compromising primary outcome
  • Bilateral cataracts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months
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).
6 Months Postoperative
Spectacle Independence
Time Frame: 6 Months
The percentage of patients reporting spectacle independence (no longer needing to wear glasses).
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 23, 2010

Last Update Submitted That Met QC Criteria

March 19, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M07-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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