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Original Investigation
January 2017

Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies

Author Affiliations
  • 1Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
  • 2Department of Ophthalmology, Navy Refractive Surgery Center, Navy Medical Center San Diego, San Diego, California
  • 3The Emmes Corporation, Rockville, Maryland
  • 4Department of Medicine, University of California, Los Angeles
  • 5National Eye Institute, Bethesda, Maryland
  • 6Viewpoint Editor, JAMA Ophthalmology
JAMA Ophthalmol. 2017;135(1):13-22. doi:10.1001/jamaophthalmol.2016.4587
Key Points

Question  What are the rates of visual and ocular symptoms and the satisfaction prevalence among civilian and military patients who underwent laser in situ keratomileusis (LASIK) surgery?

Findings  In 2 prospective, observational studies of participants undergoing LASIK surgery for myopia, hyperopia, and/or astigmatism, a large proportion reported decreases in visual symptoms, while many participants without visual symptoms at baseline developed symptoms following the procedure; participants were more likely to report visual symptoms on the questionnaire than to their health care professionals. Although visual symptoms were common, few participants reported functionally important limitations due to symptoms.

Meaning  These findings suggest that the systematic administration of a valid questionnaire to patients who had undergone LASIK surgery more accurately assesses symptoms and satisfaction.

Abstract

Importance  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.

Design, Setting, and Participants  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).

Exposures  Participants underwent LASIK surgery for myopia, hyperopia, and/or astigmatism.

Main Outcomes and Measures  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 and Relevance  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.

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