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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:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00344578
First received: June 23, 2006
Last updated: March 22, 2011
Last verified: June 2006
History of Changes
  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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344578

Locations
United States, Texas
UTSW Medical Center at Dallas
Dallas, Texas, United States, 75390
Aston Ambulatory Care Center
Dallas, Texas, United States, 75390-8866
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

No publications provided

Responsible Party: Adam Fedyk, MD, UTSW Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00344578     History of Changes
Other Study ID Numbers: Fedyk001
Study First Received: June 23, 2006
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013