Patient-Reported Outcomes With LASIK:PROWL-1

NCT01526291 | Completed DMC

• 1 other identifier: NMCSD.2010.0103
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Laser in Situ Keratomileusis

Keywords

Myopia; Hyperopia; Astigmatism; Patient-reported outcomes; Patient satisfaction; Refractive Error; Emmetropia; Dry eyes; glare; halos; patient expectations

Eligibility Criteria

• Age: 21 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Food and Drug Administration (FDA): lead
• United States Department of Defense: collaborator
• United States Naval Medical Center, San Diego: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

US Naval Medical Center, San Diego

San Diego, California, 92134, United States

Location

Related Publications (2)

• Eydelman M, Hilmantel G, Tarver ME, Hofmeister EM, May J, Hammel K, Hays RD, Ferris F 3rd. Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies. JAMA Ophthalmol. 2017 Jan 1;135(1):13-22. doi: 10.1001/jamaophthalmol.2016.4587.

  PMID: 27893066 RESULT

• Hays RD, Tarver ME, Spritzer KL, Reise S, Hilmantel G, Hofmeister EM, Hammel K, May J, Ferris F 3rd, Eydelman M. Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL). JAMA Ophthalmol. 2017 Jan 1;135(1):3-12. doi: 10.1001/jamaophthalmol.2016.4597.

  PMID: 27893063 RESULT

Related Links

• Full Manuscript Eydelman et al

MeSH Terms

Conditions

Myopia; Hyperopia; Astigmatism; Patient Satisfaction; Refractive Errors; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Lacrimal Apparatus Diseases

Study Officials

• Elizabeth M Hofmeister, MD

  US Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

• Malvina Eydelman

  US FDA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 3, 2012
• Study Start: August 1, 2011
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

US (1)