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

Tracking Information

First Received Date ^ICMJE

June 23, 2006

Last Updated Date

March 22, 2011

Start Date ^ICMJE

March 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00344578 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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:

Visual acuity with and without correction of distance and near at 3-6 months
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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Outcomes Following Restor IOL Lens Implant

Intervention ^ICMJE

Device: Restor IOL

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

120

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00344578

Other Study ID Numbers ^ICMJE

Fedyk001

Has Data Monitoring Committee

Responsible Party

Adam Fedyk, MD, UTSW Medical Center at Dallas

Study Sponsor ^ICMJE

University of Texas Southwestern Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of Texas Southwestern Medical Center

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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