Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

June 30, 2010 updated by: Alcon Research

Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation

The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

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

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
  • 50~75 years of age
  • <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.

Exclusion Criteria:

  • Patients with pre-existing conditions that could skew the results.
  • Any of conditions before and during surgery specified in the product information.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ReSTOR Aspheric IOL
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Device: AcrySof ReSTOR Aspheric IOL
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected and Best Corrected Visual Acuities (Near and Distance)
Time Frame: 6 Months Following Cataract Surgery
Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. 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 Following Cataract Surgery

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

December 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

July 30, 2010

Last Update Submitted That Met QC Criteria

June 30, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-08-001

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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