• 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 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.  

    Steering Committee

    Barbara Hawkins, PhD
    Christopher Rapuano, MD
    Michael Raizman, MD
    Donald Patrick, PhD
    Michael Twa, OD, PhD
    Janice Austin Clayton, MD
    Matthew Caldwell, MD
    Donna Peterson
    Jayne Weiss, MD
    Barbara Berney

    Study Group

    C. Pat Wilkinson, MD
    Keri Hammel
    Rick Ferris, MD
    Gene Hilmantel
    Eva Rorer, MD
    CAPT Elizabeth Hofmeister, MD
    Ron Hays, PhD
    Karen L. Spritzer
    Steve Reise, PhD
    Jeanine May
    Supriya Menezes

    Clinical Sites

    Vance Thompson
    Daniel Durrie, MD
    Kraig S. Bower, MD
    Ed Manche, MD
    William Zeh, MD
    CAPT Elizabeth Hofmeister, MD

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