Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00720005
First received: July 18, 2008
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Cataract
Device: Aspheric Acrysof ReSTOR intraocular lens
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aspheric Acrysof ResTOR Lens
Implantation of Aspheric Acrysof ResTOR
Device: Aspheric Acrysof ReSTOR intraocular lens
Bilateral implantation of Aspheric Acrysof ReSTOR
Other Name: Acrysof ReSTOR

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects 18 years or older who had cataract surgery.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720005

Locations
United States, South Carolina
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kerry D. Solomon, MD Assistant Professor
  More Information

No publications provided

Responsible Party: Kerry D Solomon, MD, Storm Eye Institute - Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00720005     History of Changes
Other Study ID Numbers: MRC-07-002
Study First Received: July 18, 2008
Last Updated: October 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Cataract
cataract extraction
intraocular lens
age related

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on October 23, 2014