Keratomileusis, Laser In SituNCT00344604
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)
An observational study of Keratomileusis, Laser In Situ, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
To evaluate the changes in quality of life parameters after LASIK surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratomileusis, Laser In Situ
- What is being tested?
- Role of psychosocial and quality of life parameters prior to and following LASIK.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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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Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8866
About this study
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)
To evaluate the changes in quality of life parameters after LASIK surgery.
Read the 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.
- Conditions
- Keratomileusis, Laser In Situ
- Being tested
- Role of psychosocial and quality of life parameters prior to and following LASIK.
- Keywords
- Patients who have undergone routine LASIK as a primary refractive procedure for myopia, hyperopia, or astigmatism.
- Medical subject headings
- Hyperopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Role of psychosocial and quality of life parameters prior to and following LASIK.Behavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startMar 2004
- Study completionJun 2006
Why it stopped: PI decided to terminate the study at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratomileusis, Laser In SituStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Shady Awwad, M.D., Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344604
- Sponsor's protocol ID
- 032004-028
- Status last verified
- Dec 2018
- First submitted
- 23 Jun 2006
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00344604
- Acronym / sponsor ID
- 032004-028
- Conditions
- Keratomileusis, Laser In Situ
- Keywords
- Patients who have undergone routine LASIK as a primary refractive procedure for myopia, hyperopia, or astigmatism.
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI decided to terminate the study at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Jun 2006 (actual)
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the changes in quality of life parameters after LASIK surgery.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Role of psychosocial and quality of life parameters prior to and following LASIK. | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shady Awwad, M.D. principal investigator
University of Texas, Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratomileusis, Laser In Situ, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.