Patient-Reported Outcomes Following LASIK Quality of Life in the PROWL Studies

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 studieswere prospective, observational studies conducted from September 13, 2011, to June 27, 2014. ThePROWL-1 studywas a single-military center study of 262 active-dutyNavy personnel 21 to 52 years of age. ThePROWL-2 studywas 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 carewere performed based on the usual practice and clinical judgment at the site. Participants completed a selfadministered, web-based questionnaire, preoperatively and postoperatively at 1 and 3 months (thePROWL-1 and -2 studies) and at 6 months (thePROWL-2 study). EXPOSURES Participants underwent LASIK surgery formyopia, hyperopia, and/or astigmatism. MAINOUTCOMESANDMEASURESVisualsymptoms(doubleimages, glare, halos, and/or starbursts), dry eye symptoms, participant satisfaction (with visionandLASIK surgery),andclinicalmeasures (visual acuity, refractive error, and slitlamp and posterior segment eyeexaminationfindings)wereassessedpreoperativelyandat1,3, and 6 months postoperatively. RESULTS Atotal of 262 participantswere enrolled in thePROWL-1 study(mean[SD]age,29.1[6.1]years),andatotalof312participants wereenrolledinthePROWL-2study(mean[SD]age,31.5[7.3]years). Visual symptoms and dissatisfaction with visionwerecommon preoperatively.Overall,theprevalenceofvisualsymptomsanddry eye symptoms decreased, although a substantial percentage of participantsreportednewvisualsymptomsaftersurgery(43%[95% CI,31%-55%]fromthePROWL-1studyand46%[95%CI,33%-58%] from thePROWL-2 study at 3 months). The percentages of participants in thePROWL-1 study with normal Ocular Surface Disease Index scoreswere 55%(95%CI, 48%-61%) at baseline, 66%(95%CI,59%-72%)at3months,and73%(95%CI,67%-79%) at6months.ThepercentagesofparticipantsinthePROWL-2study with normal Ocular Surface Disease Index scoreswere44%(95% CI,38%-50%)atbaselineand65%(95%CI,59%-71%)at3months. Ofthoseparticipantswhohadnormalscoresatbaselineinboththe PROWL-1and-2studies, about28%(95%CI,19%-37%)hadmild, moderate, or severe dry eye symptoms at 3 months. While most participantswere satisfied, the rates of dissatisfaction with vision rangedfrom1%(95%CI,0%-4%)to4%(95%CI,2%-7%),andthe rates of dissatisfaction with surgery ranged from1%(95%CI, 0%-4%) to 2%(95%CI, 1%-5%). CONCLUSIONS AND RELEVANCE The systematic administration of a questionnaire to patientswhohave 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. © 2017 American Medical Association.