The Role of Psychosocial and Other Quality of Life Parameters in Evaluating Functional Changes Prior to and Following Laser in-Situ Keratomileusis (LASIK)Changes Laser in-Situ Keratomileusis (LASIK)

This study has been terminated.
(PI decided to terminate the study at this time)
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00344604
First received: June 23, 2006
Last updated: June 19, 2008
Last verified: June 2008
  Purpose

To evaluate the changes in quality of life parameters after LASIK surgery.


Condition Intervention
Keratomileusis, Laser In Situ
Behavioral: Role of psychosocial and quality of life parameters prior to and following LASIK.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Role of Psychosocial and Other Quality of Life Parameters in Evaluating Functional Changes Prior to and Following Laser in-Situ Keratomileusis (LASIK)

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

Enrollment: 0
Study Start Date: March 2004
Study Completion Date: June 2006
Detailed Description:

Our purpose is to evaluate the changes in quality of life parameters after LASIK surgery. We intend to create a questionnaire to delineate the changes that occur in LASIK patients at the pre-operative visit and at the 1-month and 3-month post-operative visits. Additional questionnaires will be administered to demonstrate the validity of the new questionnaire. The approximate time the patient will be required to spend in clinic will be approximately 45 minutes at each of the three visits.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: All refractive surgery patients with otherwise normal eyes undergoing routine LASIK as a primary refractive procedure for myopia, hyperopia or astigmatism.

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Exclusion Criteria: Patients who elect to perform alternative refractive surgery such as PRK, RK, or Intacts™.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344604

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

No publications provided

Responsible Party: James P. McCulley, UTSW Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00344604     History of Changes
Other Study ID Numbers: 032004-028
Study First Received: June 23, 2006
Last Updated: June 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Patients who have undergone routine LASIK as a primary refractive procedure for myopia, hyperopia, or astigmatism.

ClinicalTrials.gov processed this record on October 19, 2014