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Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345085
First Posted: June 27, 2006
Last Update Posted: July 25, 2014
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
This project involves evaluation of post operative contrast sensitivity and wavefront aberration results among patients implanted with standard monofocal lenses (Acrysof SN60AT/SN60WF) and the new presbyopic correcting multifocal lens (Acrysof ReSTOR). Higher Order aberrations are visual phenomena such as glare and haloes. They are more prevalent after cataract surgery and can affect night driving.

Condition Intervention
Refractive Errors Device: Wavefront and Contrast Sensitivity

Study Type: Observational
Official Title: Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses

Resource links provided by NLM:


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

Primary Outcome Measures:
  • post operative wavefront aberration

Secondary Outcome Measures:
  • post operative contrast sensitivity

Enrollment: 40
Study Start Date: March 2005
Study Completion Date: April 2007
Detailed Description:
The Project involves evaluation of contrast sensitivity and higher order aberrations in patients implanted with SN60AT, SN60WF and ReSTOR intraocular lenses. Patients in the department of Ophthalmology will be asked to participate in the study on a routine postoperative visit at least 3 months after cataract surgery. Patients will be asked to sign a consent form prior to participation. Wavefront analysis involves the patient resting their chin in a device similar to a slit lamp; they focus on a distant light and the machine performs the measurements in mesopic and scotopic conditions (light and dark). Contrast sensitivity is a measure of how faded or washed out an image can be before it becomes indistinguishable from a uniform field; it involves the patient identifying patterns on a chart. Wavefront analysis and contrast sensitivity are noninvasive tests that do not employ sedation or anesthesia and does not expose the patient to x-rays or microwaves. The proposed research will not alter usual standard postoperative care and can be done on a routine office visit.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: All subject implanted with either SN60AT, SN60WF or ReSTOR intraocular lenses after cataract removal. Subjects include those 18 yrs and over, male and female, all races. Patients will sign an informed consent

Exclusion Criteria: Patients younger than 18 yrs. Patients with other concurrent visually significant ophthalmic disease.

  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): NCT00345085


Locations
United States, Texas
UTSW Medical Center at Dallas
Dallas, Texas, United States, 75390-8866
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Study Chair: James P McCulley, M.D. UTSW Medical Center at Dallas
Principal Investigator: Shady Awwad, M.D. UTSW Medical Center at Dallas
  More Information

Responsible Party: James P. McCulley, MD, UTSW Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00345085     History of Changes
Other Study ID Numbers: 052006-029
First Submitted: June 23, 2006
First Posted: June 27, 2006
Last Update Posted: July 25, 2014
Last Verified: June 2008

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases