Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

May 5, 2010 updated by: Alcon Research

Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)

This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 21 years or older;
  • need spherical correction between 10-30 Diopters (D);
  • corneal astigmatism less than 0.75D as measured by keratometry;
  • willing to sign an Informed Consent Form and complete all visits;
  • pupil dilation greater than 6mm;
  • expected Visual Acuity (measured in logMAR)=0.3 or better

Exclusion Criteria:

  • Women of childbearing potential;
  • irregular corneal astigmatism;
  • keratopathy/keratectasia;
  • cornea inflammation or edema;
  • cornea reshaping surgery;
  • corneal dystrophy;corneal transplant;
  • amblyopia;
  • glaucoma;
  • Retinal Pigment Epitheliopathy (RPE)/Macular changes;
  • proliferative diabetic retinopathy

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AcrySof® ReSTOR® Aspheric IOL
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Device: AcrySof® ReSTOR® Aspheric IOL
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery
Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectacle Independence
Time Frame: pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery
Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.
pre-op;1 week,1 month,3 months and 6 months after 2nd eye 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

November 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2010

Last Update Submitted That Met QC Criteria

May 5, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALCONsur002.07

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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