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)
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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) |
| Enrollment: | 0 |
| Study Start Date: | March 2004 |
| Study Completion Date: | June 2006 |
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 |
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| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390-8866 | |
| 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 May 16, 2013