Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses
Primary Purpose
Refractive Errors
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Wavefront and Contrast Sensitivity
Sponsored by
About this trial
This is an observational trial for Refractive Errors
Eligibility 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.
Sites / Locations
- UTSW Medical Center at Dallas
Outcomes
Primary Outcome Measures
post operative wavefront aberration
Secondary Outcome Measures
post operative contrast sensitivity
Full Information
NCT ID
NCT00345085
First Posted
June 23, 2006
Last Updated
July 24, 2014
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00345085
Brief Title
Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses
Official Title
Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses
Study Type
Observational
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
7. Study Design
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Wavefront and Contrast Sensitivity
Primary Outcome Measure Information:
Title
post operative wavefront aberration
Secondary Outcome Measure Information:
Title
post operative contrast sensitivity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P McCulley, M.D.
Organizational Affiliation
UTSW Medical Center at Dallas
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shady Awwad, M.D.
Organizational Affiliation
UTSW Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTSW Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8866
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses
We'll reach out to this number within 24 hrs