title: Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies.
abstract: OBJECTIVE
  Patient-reported outcomes should be collected using validated questionnaires prior to and following laser in situ keratomileusis (LASIK) surgery.
  
  
  OBJECTIVE
  To report the frequency of patient-reported visual symptoms, dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery in the Patient-Reported Outcomes With LASIK (PROWL) studies.
  
  
  METHODS
  The PROWL-1 and PROWL-2 studies were prospective, observational studies conducted from September 13, 2011, to June 27, 2014. The PROWL-1 study was a single-military center study of 262 active-duty Navy personnel 21 to 52 years of age. The PROWL-2 study was a study of 312 civilians 21 to 57 years of age conducted at 5 private practice and academic centers. The LASIK surgery and the postoperative care were performed based on the usual practice and clinical judgment at the site. Participants completed a self-administered, web-based questionnaire, preoperatively and postoperatively at 1 and 3 months (the PROWL-1 and -2 studies) and at 6 months (the PROWL-2 study).
  
  
  METHODS
  Participants underwent LASIK surgery for myopia, hyperopia, and/or astigmatism.
  
  
  METHODS
  Visual symptoms (double images, glare, halos, and/or starbursts), dry eye symptoms, participant satisfaction (with vision and LASIK surgery), and clinical measures (visual acuity, refractive error, and slitlamp and posterior segment eye examination findings) were assessed preoperatively and at 1, 3, and 6 months postoperatively.
  
  
  RESULTS
  A total of 262 participants were enrolled in the PROWL-1 study (mean [SD] age, 29.1 [6.1] years), and a total of 312 participants were enrolled in the PROWL-2 study (mean [SD] age, 31.5 [7.3] years). Visual symptoms and dissatisfaction with vision were common preoperatively. Overall, the prevalence of visual symptoms and dry eye symptoms decreased, although a substantial percentage of participants reported new visual symptoms after surgery (43% [95% CI, 31%-55%] from the PROWL-1 study and 46% [95% CI, 33%-58%] from the PROWL-2 study at 3 months). The percentages of participants in the PROWL-1 study with normal Ocular Surface Disease Index scores were 55% (95% CI, 48%-61%) at baseline, 66% (95% CI, 59%-72%) at 3 months, and 73% (95% CI, 67%-79%) at 6 months. The percentages of participants in the PROWL-2 study with normal Ocular Surface Disease Index scores were 44% (95% CI, 38%-50%) at baseline and 65% (95% CI, 59%-71%) at 3 months. Of those participants who had normal scores at baseline in both the PROWL-1 and -2 studies, about 28% (95% CI, 19%-37%) had mild, moderate, or severe dry eye symptoms at 3 months. While most participants were satisfied, the rates of dissatisfaction with vision ranged from 1% (95% CI, 0%-4%) to 4% (95% CI, 2%-7%), and the rates of dissatisfaction with surgery ranged from 1% (95% CI, 0%-4%) to 2% (95% CI, 1%-5%).
  
  
  CONCLUSIONS
  The systematic administration of a questionnaire to patients who have undergone LASIK surgery is a new approach to assess symptoms and satisfaction. Our findings support the need for adequate counseling about the possibility of developing new symptoms after LASIK surgery.
authors.affiliation: Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Malvina
authors.initials: M
authors.lastname: Eydelman
authors.affiliation: Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Gene
authors.initials: G
authors.lastname: Hilmantel
authors.affiliation: Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Tarver
authors.affiliation: Department of Ophthalmology, Navy Refractive Surgery Center, Navy Medical Center San Diego, San Diego, California.
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Hofmeister
authors.affiliation: The Emmes Corporation, Rockville, Maryland.
authors.forename: Jeanine
authors.initials: J
authors.lastname: May
authors.affiliation: The Emmes Corporation, Rockville, Maryland.
authors.forename: Keri
authors.initials: K
authors.lastname: Hammel
authors.affiliation: Department of Medicine, University of California, Los Angeles.
authors.forename: Ron D
authors.initials: RD
authors.lastname: Hays
authors.affiliation: National Eye Institute, Bethesda, Maryland6Viewpoint Editor, JAMA Ophthalmology.
authors.forename: Frederick
authors.initials: F
authors.lastname: Ferris
mesh_terms: D000328:Adult; D001251:Astigmatism / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D005260:Female; D006801:Humans; D020731:Keratomileusis, Laser In Situ / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D014792:Visual Acuity; D055815:Young Adult