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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 PARTICIPANTSThe 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 MEASURESVisual 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 RELEVANCEThe systematic administration of a questionnaire to patients who have undergone LASIK surgery is a new approach to assess symptoms and satisfaction. Our findi...

PURPOSE:To develop a minimum set of analyses and a format for presentation of outcomes of astigmatism correction by laser systems that reshape the cornea.

This paper (1) reviews the fundamental limits to visual performance imposed by optical imaging and photoreceptor sampling to determine the limits to the potential gains offered by ideal corrections; (2) examines the predicted losses in vision induced by chromatic aberration, phase shifts, typical ocular aberrations, and the gains possible by correcting the monochromatic aberrations of the eye; (3) discusses the principles of aberration measurement in the eye; and (4) presents methods for measuring and classifying monochromatic aberrations of the eye. J Cataract Refract Surg 2001; 27:1093-1107© 2001 F or the first time in history, it is possible to clinically measure the optical defects of the eye beyond sphere and cylinder quickly and efficiently in the clinical environment. By all indications, this technology will soon work its way into clinical practice. Several companies currently use or plan to use this technology to quantify ocular aberrations to design ideal refractive corrections. These optimal corrections are intended to improve the optical quality of the retinal image beyond what is achievable with traditional spherocylindrical corrections. "Ideal" corrections may come in the form of customized corneal ablative corrections, contact lenses, intraocular lenses, or a combination of these.1 Once the aberrations of the eye are quantified, they can be minimized using adaptive mirrors or other means to improve the ophthalmoscopic view of the fundus. Such techniques are referred to collectively as adaptive optics and are being used to improve the ophthalmoscopic view of the retina down to the level of individual photoreceptors.2,3 Similarly, adaptive optics have been used to improve vision and show potential patients the benefit of reducing ocular aberrations. 4 Currently, it is not clear that ideal corrections can be implemented routinely or that such corrections will routinely result in "super vision"; ie, vision that is significantly improved over that provided by more traditional forms of correction. Surgeries generally increase corneal [5][6][7][8] and total eye 9 aberrations. Nonetheless, preliminary results with wavefront-guided surgery are encouraging (a decrease in the surgically induced aberrations 10 and in 1 report, a reduction in the normal

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The prevalence of myopia is high and increasing. Approximately 5 billion people around the world are expected to be myopic by the year 2050. Methods to slow the progression of myopia and therefore potentially decrease the associated sight-threatening complications have been the subject of a number of investigations. A workshop, sponsored by the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists, Inc, convened myopia experts from around the world to discuss principles to consider in the design of clinical trials investigating the effectiveness and safety of myopia control devices. Experts discussed parameters such as study endpoints, duration, enrollment criteria, patient-reported outcomes, recruitment, and retention. The discussions among the experts, FDA, and audience members should help to facilitate the development and evaluation of reasonably safe and effective myopia control devices.

IMPORTANCE Patient-reported outcome (PRO) measures for laser in situ keratomileusis (LASIK) are needed.OBJECTIVE To develop PRO measures to assess satisfaction, eye-related symptoms, and their effect on functioning and well-being following LASIK based on patient and expert input. DESIGN, SETTING, AND PARTICIPANTSThe Patient-Reported Outcomes With LASIK (PROWL) studies were prospective observational studies of patients undergoing LASIK surgery for myopia, hyperopia, or astigmatism. PROWL-1 was a single-center study of active-duty US Navy personnel and PROWL-2 was a 5-center study of civilians. PROWL-1 enrolled 262 active-duty service personnel and PROWL-2 enrolled 312 civilians 21 years or older who spoke English; 241 individuals in PROWL-1 and 280 in PROWL-2 completed a baseline questionnaire before surgery. The analytic sample included those also completing 1 or more follow-up questionnaires: 240 (99.6%) of those in PROWL-1 and 271 (94.4%) of those in PROWL-2. Questionnaires were self-administered through the internet preoperatively and at 1 and 3 months postoperatively in both studies and at 6 months postoperatively in PROWL-1.

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