Eyeworld

97 EW REFRACTIVE SURGERY March 2015 Contact information Eydelman: malvina.eydelman@fda.hhs.gov Hofmeister: elizabeth.hofmeister@med.navy.mil Manche: edward.manche@stanford.edu Stulting: dstulting@woolfsoneye.com The FDA will make the question- naire available to researchers inter- ested in this area." The studies show that there is a firm grasp on the symptoms that patients generally report after LASIK, Dr. Hofmeister said. "This understanding can and should permit surgeons to provide a more focused and effective informed consent to our LASIK patients," she said. She hopes the questionnaire will be a useful tool for studying LASIK and other refractive procedures. The project was designed to develop and utilize a new question- naire that assessed patients' reported experiences before and after surgery, Dr. Eydelman said, which was not done in earlier studies. "In the future, the questionnaire we produced can be used to more thoroughly assess candidates before LASIK surgery; monitor them for visual symptoms after LASIK surgery; and in further research identify which patients are likely to experi- ence serious difficulties," she said. Dr. Eydelman said the study established a starting point for accu- rately assessing the impact of visual symptoms on subjects' functioning, as well as determining how bother- some those symptoms are. "The findings from this study will help to refine [the] FDA's cur- rent thoughts on the labeling for LASIK devices, which will be incor- porated into our LASIK guidance," Dr. Eydelman said. Additionally, the questionnaire content will be publicly available for use in clinical trials of LASIK devices, as a tool in clinical care, and for future research endeavors. There were some patients who experienced some negative effects in the study, but Dr. Eydelman noted that the percentage of subjects ex- periencing disabling symptoms was low. However, she said that anyone contemplating LASIK should be aware of this risk. Dr. Manche thinks that this was a well-designed study. However, he does take some issue with measuring symptoms at 3 months because they are not necessarily representative. This should have been carried out to a year, he said. "I think it's a well-done study in that it was prospective in nature, multicenter, and it was done with the FDA and [National Eye Institute]," he said. The study provides good answers for those patients thinking of having LASIK, he said. EW Editors' note: Drs. Eydelman, Manche, Hofmeister, and Stulting have no finan- cial interests related to this article. PATENT NO. 8,875,405 PATENT NO. D639,432 ASCRS Booth #1117 Join OASIS to experience the latest SOFT CELL ® PLUS PVA Foam products and newly redesigned Premier Edge ® Safety Scalpels. Premier Edge ® Safety Scalpels X Supports compliance with OSHA 1910.1030(d)(2)(i) and 1910.1030(d)(2)(vii)(B) X The natural sliding thumb motion supports one-handed operation and ambidextrous usability X Designed for minimal variation of balance and weight from standard Premier Edge ® Scalpels X Patented and ergonomically designed safety shield with ribbed thumb-grip X Safety shield secures with a distinctive click SOFT CELL ® PLUS PVA Foam Spears X Designed for ease of tissue manipulation X Fiber-free with high absorption X Firm PVA foam Contact OASIS for a trial of Premier Edge ® Safety Scalpels and SOFT CELL ® PLUS PVA Foam products. (844) 266-2747 oasis@oasismedical.com www.oasismedical.com © 2015 OASIS Medical, Inc. OASIS name and logo are registered trademarks of OASIS Medical, Inc. 514 S. Vermont Ave, Glendora, CA 91741. LIT-SURG-AD 2.2015 Get these OASIS products and more through the OASIS BULK PROGRAM. A cost-conscious way to customize inventory management and increase efficiency. Ref # PE3015-SL Ref # 0530

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