Visual Performance of Bilateral AcrySof ReSTOR Aspheric +4

October 4, 2010 updated by: Alcon Research
Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain spectacle freedom.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

17

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
        • Contact 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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants taken from physician's patient pool implanted with the AcrySof ReSTOR +4 Intraocular Lens (IOL)

Description

Inclusion Criteria:

  • Diagnosed with cataracts

Exclusion Criteria:

  • Preexisting conditions confounding results; > 1 Diopter preoperative astigmatism

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ReSTOR +4
AcrySof ReSTOR Aspheric +4
Device: AcrySof ReSTOR Aspheric +4
Implantation with the AcrySof ReSTOR Aspheric +4 Multifocal Intraocular Lens (IOL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Contrast sensitivity, patient survey
Time Frame: 6 months
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 Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

October 4, 2010

First Posted (Estimate)

October 5, 2010

Study Record Updates

Last Update Posted (Estimate)

October 5, 2010

Last Update Submitted That Met QC Criteria

October 4, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M07-004

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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