Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

October 1, 2010 updated by: Medical University of South Carolina
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.

Study Type

Observational

Enrollment (Actual)

20

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
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Storm Eye Institute, Medical University of South Carolina

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

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects 18 years or older who had cataract surgery.

Description

Inclusion Criteria:

  • Subject must have an age-related cataract in both eyes.
  • 40 years of age or older.
  • Patient must desire cataract extraction.
  • Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
  • Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

  • Preoperative ocular pathology potentially affecting visual acuity.
  • Keratometric astigmatism exceeding 1.50 diopters.
  • Planned postoperative refraction for mono-vision.
  • Uncontrolled diabetes.
  • Use of any systemic or topical drug known to interfere with visual performance.
  • Contact lens use during the active treatment portion of the trial.
  • Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
  • Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
  • Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
  • Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
  • Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
  • Other ocular surgery at the time of the cataract extraction.

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aspheric Acrysof ResTOR Lens
Implantation of Aspheric Acrysof ResTOR
Device: Aspheric Acrysof ReSTOR intraocular lens
Bilateral implantation of Aspheric Acrysof ReSTOR
Other Names:
  • Acrysof ReSTOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance).
Time Frame: Preoperatively, 1, 3 and 6 months postoperatively
Preoperatively, 1, 3 and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
pupil size and contrast sensitivity under photopic and mesopic conditions wearing the best distance correction (the latter per eye and both eyes. Slit-lamp exam, eye dominance, reading speed test, and a quality of vision questionnaire.
Time Frame: preoperatively, 1, 3, 6 month
preoperatively, 1, 3, 6 month

Collaborators and Investigators

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

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Kerry D. Solomon, MD, Assistant Professor

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

September 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 21, 2008

First Posted (Estimate)

July 22, 2008

Study Record Updates

Last Update Posted (Estimate)

October 4, 2010

Last Update Submitted That Met QC Criteria

October 1, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-07-002

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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