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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00344578
Collaborator
(none)
120
2
16
60
3.8

Study Details

Study Description

Brief Summary

To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW Medical Center at Dallas

Condition or Disease Intervention/Treatment Phase
  • Device: Restor IOL

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
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
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Outcome Measures

Primary Outcome Measures

  1. 1)Visual acuity with and without correction of distance and near at 3-6 months []

Secondary Outcome Measures

  1. Percent of patients requiring keratorefractive surgery []

  2. Ocular comorbidity subgroup analysis []

  3. Monocular implantation subanalysis (prior to LASIK) []

  4. Comparison of post-op spherical equivalent to target refraction []

  5. Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy? []

  6. Subjective patient satisfaction []

  7. Validated questionnaire assessing visual function and quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Aston Ambulatory Care Center Dallas Texas United States 75390-8866
2 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00344578
Other Study ID Numbers:
  • Fedyk001
First Posted:
Jun 27, 2006
Last Update Posted:
Mar 23, 2011
Last Verified:
Jun 1, 2006
Keywords provided by , ,

Study Results

No Results Posted as of Mar 23, 2011