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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Wavefront and Contrast Sensitivity

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-8866
      • UTSW Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
post operative wavefront aberration

Secondary Outcome Measures

Outcome Measure
post operative contrast sensitivity

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: June 23, 2006
• First Submitted That Met QC Criteria: June 23, 2006
• First Posted (Estimate): June 27, 2006

Study Record Updates

• Last Update Posted (Estimate): July 25, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 052006-029