Patient-Reported Outcomes With LASIK:PROWL-1

This study has been completed.
Sponsor:
Collaborators:
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier:
NCT01526291
First received: January 31, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

This study evaluates a questionnaire designed to measure satisfaction and ophthalmic-related quality of life (QOL)in up to 550 active duty subjects prior to and six months following state-of-the-art laser in situ keratomileusis (LASIK).


Condition
Laser in Situ Keratomileusis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient-Reported Outcomes With LASIK:PROWL-1

Further study details as provided by Food and Drug Administration (FDA):

Estimated Enrollment: 550
Study Start Date: August 2011
Detailed Description:

The LASIK Quality of Life Collaboration Project (LQOLCP) is a government partnership among the FDA, the Department of Defense, and the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs) following LASIK. This three-phased project is part of FDA's ongoing effort to better monitor and improve the safety and effectiveness of lasers used in LASIK surgery. PROWL-1 is the second phase of the larger LQOLCP project. This prospective, questionnaire-based study will be conducted by the Navy Refractive Surgery Center San Diego in collaboration with the U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) and the National Eye Institute (NEI). The primary purpose of this study is to explore the psychometric properties of a newly developed questionnaire assessing satisfaction and ophthalmic-related quality of life (QOL) in 550 active duty patients over a period of six months prior to and following state-of-the-art laser in situ keratomileusis (LASIK). Specific topics of interest include: functional limitations, dry eye symptoms, pre-operative expectations, depression, anxiety, post-operative symptoms, dispositional optimism, and satisfaction. Additionally, standard-of-care, non-invasive clinical data will be collected pre- and postoperatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, corneal topography, and other clinical assessments), and analyzed. The questionnaire in this study is a newly developed instrument which, once psychometrically evaluated in this U.S. Navy/FDA/NEI collaboration, will be used in future large-scale, multicenter FDA clinical studies that include civilian refractive surgery centers throughout the United States.

  Eligibility

Ages Eligible for Study:   21 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Active duty service members residing in San Diego, CA and planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism

Criteria

Inclusion Criteria:

  • Male or female active duty service member, of any race, and at least 21 years old at the time of the pre-operative examination.
  • Speak and read English fluently, and have the ability to give informed consent.
  • Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50 D for myopes or 0.75D for hyperopes during the 12-month period immediately preceding the baseline pre-operative examination.
  • Soft contact lens users must have removed their lenses at least 1 week before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses must have removed their lenses at least 4 weeks prior to baseline measurements, and have 2 central keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50D in either meridian; mires shall be regular.
  • Express strong motivation and potential ability to return for all follow-up examinations through the 6-month follow-up exam under the care of the treating investigator, and have access to transportation to meet follow-up requirements.
  • Reside in the greater San Diego, California metropolitan area.
  • Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical ophthalmic health, general cognitive function, and physical and social limitations.
  • Have a treatment target of bilateral emmetropia or possibly slight hyperopia (+0.25D).
  • Have access to a computer with internet service.
  • Consent of the subject's command to participate in the study.

Exclusion Criteria:

  • Previous introcular or corneal surgery of any kind in either eye, including any type of surgery for either refractive or therapeutic purposes.
  • Female subjects who are pregnant or breast-feeding, or intend to become pregnant during the 6 month duration of the study.
  • Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and sumatriptin (Imitrex) or any other tryptan.
  • Active ophthalmic disease, neovascularization of the cornea within 1 mm of the intended ablation zone, clinically significant lens opacity, or clinically significant dry eye syndrome unresolved by treatment.
  • Evidence of glaucoma or intraocular pressure greater than 22mmHg at baseline.
  • Evidence of keratonconus, corneal irregularity, or abnormal videokeratography in either eye.
  • Corneal thickness insufficient to allow the residual remaining stromal bed to be no less than 300 microns in each eye. The residual stromal bed thickness will be determined by subtracting both the LASIK flap thickness and depth of the ablation from the total central corneal thickness measured by pachymetry.
  • History of recurrent erosions or epithelial basement dystrophy.
  • Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526291

Locations
United States, California
US Naval Medical Center, San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
Food and Drug Administration (FDA)
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Elizabeth M Hofmeister, MD US Naval Medical Center, San Diego
Principal Investigator: Malvina Eydelman US FDA
  More Information

No publications provided

Responsible Party: Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier: NCT01526291     History of Changes
Other Study ID Numbers: NMCSD.2010.0103
Study First Received: January 31, 2012
Last Updated: February 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Food and Drug Administration (FDA):
Myopia
Hyperopia
Astigmatism
Patient-reported outcomes
Patient satisfaction
Refractive Error
Emmetropia
Dry eyes
glare
halos
patient expectations

ClinicalTrials.gov processed this record on April 16, 2014