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Clinical Outcomes After AcrySof® ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas: A Retrospective Review

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00344578
First Posted: June 27, 2006
Last Update Posted: March 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Texas Southwestern Medical Center
  Purpose
To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW Medical Center at Dallas

Condition Intervention Phase
Outcomes Following Restor IOL Lens Implant Device: Restor IOL Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Outcomes After AcrySof® ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas: A Retrospective Review

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 1)Visual acuity with and without correction of distance and near at 3-6 months

Secondary Outcome Measures:
  • Percent of patients requiring keratorefractive surgery
  • Ocular comorbidity subgroup analysis
  • Monocular implantation subanalysis (prior to LASIK)
  • Comparison of post-op spherical equivalent to target refraction
  • Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?
  • Subjective patient satisfaction
  • Validated questionnaire assessing visual function and quality of life

Estimated Enrollment: 120
Study Start Date: March 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The AcrySof® ReSTOR® intraocular lens (IOL) is the latest advance in vision surgery. This IOL has been uniquely designed to improve vision throughout the entire visual spectrum, up close, far away and everything in-between. Thus, giving cataract patients their best chance ever to function free of glasses.

The pre-operative and post-operative data from ReSTOR® IOL implant cataract surgeries will be analyzed to determine whether the desired outcome was achieved, i.e. excellent vision with no correction. Variables to be studied include patient age, gender, number of ReSTOR® IOL implants, ocular comorbidities, preoperative and postoperative corrected and uncorrected visual acuities, keratometry readings, and corneal topography readings. A patient survey will also be sent to patients having undergone the surgery to measure their level of satisfaction.

Project Goals: The ultimate outcome of this project is to learn more insight on the following:

  1. Visual acuity with and without correction of distance and near at 3-6 months
  2. Percent of patients requiring keratorefractive surgery
  3. Ocular comorbidity subgroup analysis
  4. Monocular implantation subanalysis (prior to LASIK)
  5. Comparison of post-op spherical equivalent to target refraction
  6. Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?
  7. Subjective patient satisfaction
  8. Validated questionnaire assessing visual function and quality of life
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.
Criteria

Inclusion Criteria:

All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.

Exclusion Criteria:

Patients who underwent conventional IOL cataract extraction surgery

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344578


Locations
United States, Texas
Aston Ambulatory Care Center
Dallas, Texas, United States, 75390-8866
UTSW Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Adam Fedyk, MD UTSW Medical Center at Dallas
Study Director: Vinod Mootha, MD UTSW Medical Center at Dallas
Study Chair: James McCulley, MD UTSW Medical Center at Dallas
  More Information

Responsible Party: Adam Fedyk, MD, UTSW Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00344578     History of Changes
Other Study ID Numbers: Fedyk001
First Submitted: June 23, 2006
First Posted: June 27, 2006
Last Update Posted: March 23, 2011
Last Verified: June 2006

Keywords provided by University of Texas Southwestern Medical Center:
Higher Order Abberations