• Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) and Scoring Guide

    Steward: H. Dunbar Hoskins Jr., MD, Center for Quality Eye Care, American Academy of Ophthalmology

    Acknowledgments

    The Academy acknowledges the contributions of Ron D. Hays, PhD, and Karen L. Spritzer, UCLA Department of Medicine, in developing and evaluating this instrument.  

    The Academy also acknowledges the dedicated efforts of Malvina Eydelman, MD (Director, Office of Health Technology 1) and Michelle Tarver, MD, PhD, Deputy Director, Office of Strategic Partnerships and Technology Innovation, Program Director for Patient Science, Digital Health Center of Excellence, Center for Devices and Radiological Health, FDA, in the creation and completion of this questionnaire.  

    The LASIK Quality of Life Collaboration Project Members include the following: Study Group: Charles “Pat” Wilkinson, MD, Study director (Greater Baltimore Medical Center), Frederick Ferris, III, MD, Co-Primary Investigator, (National Eye Institute), Malvina Eydelman, MD, Co-Primary Investigator, (US Food and Drug Administration), Michelle E. Tarver, MD, PhD (US Food and Drug Administration), Eva Rorer, MD (US Food and Drug Administration), Rachel Bishop, MD (National Eye Institute), Gerry Gray, PhD (US Food and Drug Administration), Danica Marinac-Dabic, MD, PhD (US Food and Drug Administration), Larry Park, MD (US Food and Drug Administration), Robert Sperduto, MD (The Emmes Corporation), and Susan Vitale, PhD (National Eye Institute). Steering Committee: Charles “Pat” Wilkinson, MD (chair, Greater Baltimore Medical Center), Barbara Berney (patient representative), Matthew Caldwell, MD (US Air Force), Janine Clayton, MD (National Institutes of Health), Barbara Hawkins, PhD (Johns Hopkins Wilmer Eye Institute), Donald Patrick, PhD, MSPH (University of Washington), Donna Peterson (patient representative), Michael Raizman, MD (Ophthalmic Consultants of Boston, Inc, Tufts University), Christopher Rapuano, MD (Wills Eye Hospital and Jefferson Medical College), Michael Twa, OD, PhD (University of Houston), and Jayne Weiss, MD (Louisiana State University Eye Center). Clinical Investigators: Elizabeth M. Hofmeister, MD (Navy Medical Center San Diego), K. Scot Bower, MD, FACS (Wilmer Eye Institute), Daniel Durrie, MD (Durrie Vision), Edward Manche, MD (Stanford University School of Medicine), Vance Thompson, MD (Vance Thompson Vision/Sanford Health), and William Zeh, MD (20/20 Institute). Data Acquisition/Analysis: Steve Reise, PhD (University of California, Los Angeles), Karen Spritzer, BS (University of California, Los Angeles), Donna Murdoch, PhD (Navy Medical Center San Diego), and Erik Dekelbaum (US Food and Drug Administration).

    Qualified Context of Use

    See the FDA's Summary of Evidence and Basis of Qualification Decision.

    The paper and electronic versions of the PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness, and impact on usual activities in the last 7 days of 4 visual symptoms: double images (8 items), glare (8 items), halos (8 items), and starbursts (8 items). 

    The measure is designed to be used in patients undergoing LASIK surgery who meet the following conditions:  21 and older who speak and read English fluently; have not previously received any form of refractive surgery; are determined to be good candidates for LASIK based on their surgeon’s assessment of medical and ophthalmic health, cognitive function, and physical function, and social function; are undergoing the surgery for treatment of myopia, hyperopia and/or astigmatism; are undergoing the surgery for treatment of myopia, hyperopia, and/or astigmatism; and are targeted to get a refraction of bilateral emmetropia or slight hyperopia (+0.25 Diopters).  The four symptom scores may be used at baseline and post-surgery as secondary or additional safety assessment in clinical studies or observational studies to evaluate descriptively the subjects’ visual perception. The satisfaction with vision scale may be used at baseline and post-surgery as an additional effectiveness endpoint to evaluate descriptively changes in satisfaction from baseline.  
     
    Notes: The PROWL-SS was administered by web in the original studies. While this questionnaire content covers symptoms and satisfaction, it is also important to measure dry eye symptoms and driving function given that they have been found to be relevant to patients undergoing LASIK surgery.  

    PROWL-SS Questionnaire

    The PROWL-SS questionnaire provides the PROWL-SS questions for information purposes.

    There are 6 scores, each with a possible range of 0 to 100 (0 = worst; 100 = best possible) described in the PROWL-SS scoring guide.

    Question 1: Satisfaction with Vision                          
    Questions 2-9: Double-Image                    
    Questions 10-17: Glare  
    Questions 18-25: Halos        
    Questions 26-33: Starburst

    The IRIS Registry has the PROWL-SS that has been approved by the FDA MDDT integrated in the IRIS Registry for use.

    For questions about the PROWL-SS, please contact Flora Lum, MD, Vice President, Quality and Data Science: flum@aao.org