The Role of Psychosocial and Other Quality of Life Parame... | NCT00344604

Studies
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)

NCT00344604

Sponsor

University of Texas Southwestern Medical Center

Status

Withdrawn

Last Update Posted

Dec 13, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Keratomileusis, Laser In Situ

Interventions

Role of psychosocial and quality of life parameters prior to and following LASIK.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI decided to terminate the study at this time

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Jun 23, 2006

First Submission Date that Met QC Criteria

Jun 23, 2006

First Posted Date

Jun 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2018

Last Update Posted Date

Dec 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Role of psychosocial and quality of life parameters prior to and following LASIK.	Behavioral

Eligibility Module

Eligibility Criteria

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

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shady Awwad, M.D.	University of Texas, Southwestern Medical Center at Dallas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Southwestern Medical Center at Dallas		Dallas	Texas	75390-8866	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D006956	Hyperopia
D001251	Astigmatism

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases