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

NCT ID: NCT00344578

Last Updated: 2011-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-07-31

Brief Summary

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

Detailed Description

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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

Conditions

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Outcomes Following Restor IOL Lens Implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Restor IOL

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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UTSW Medical Center at Dallas

Principal Investigators

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Adam Fedyk, MD

Role: PRINCIPAL_INVESTIGATOR

UTSW Medical Center at Dallas

Vinod Mootha, MD

Role: STUDY_DIRECTOR

UTSW Medical Center at Dallas

James McCulley, MD

Role: STUDY_CHAIR

UTSW Medical Center at Dallas

Locations

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Aston Ambulatory Care Center

Dallas, Texas, United States

Site Status

UTSW Medical Center at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Fedyk001

Identifier Type: -

Identifier Source: org_study_id

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