Miri Hanai

On October 19, 2010, she was a patient at the Department of Defense, and National Eye Institute we report on Collaboration progress1 LASIK Quality of Life Project (LQOLCP),
government partnership between the FDA, the Department of Defense, and National Eye Institute. The project is examining the patient-reported outcome (PRO) following LASIK. A PRO is any report coming directly from patients about health conditions and treatment. This three-phased project is part of FDA's ongoing effort to better monitor and improve the safety and effectiveness of the laser used in LASIK surgery. Phase I
The first stage involves the design and implementation of web-based questionnaire to assess the results frequently reported by LASIK patients, but had not quite measured. This phase also involves interviews with patients contemplating LASIK as well as patients who have experienced a bad outcome and those who have experienced positive results. The results of these interviews have been modifications guided to the questionnaire. Phase II
The second stage involves a clinical study called the Patient-Reported results with LASIK (patrol-1), where U.S. military personnel to choose LASIK will complete questionnaires before surgery and at 1, 3, and 6 months after surgery. Registration for prowl-1 is scheduled to begin in coming months at the Naval Medical Center San Diego. Prowl-1 will be another step in the development of PRO questionnaires to better measure in preparation for the administration of the national group representative of LASIK patients. Phase III
The third stage of LQOLCP consists of two clinical studies, called-2a and-2b prowl.
Prowl-2a is a national, multi-center clinical study examining the reliability of the questionnaire (developed in Phase I and II of LQOLCP) in the civilian population. Study participants will take a questionnaire prior to LASIK surgery and then took a post-surgery questionnaire one month after surgery and again three months after surgery. Clinical information about the participants will be analyzed together with answers to their questionnaire both before and after surgery.
On March 24, 2011, the FDA and the National Eye Institute of the National Institutes of Health asked for proposals to participate in the patrol-2a of LASIK surgery site with the ability to conduct clinical research.
This is a request for proposal (RFP) from the center of the clinical course. RFP can be found at the following link https: / / secure.emmes.com/emmesweb/projects/neis2.disclaimer icon3 We do not accept applications from patients. Patients interested in participating in this study will only be registered if they receive care from providers in a location selected to participate and have not undergone LASIK surgery. Notification of selected sites is anticipated during the summer of 2011.
Prowl-2b will be using questionnaires that were previously evaluated in the civilian population to provide an estimate of the prevalence of PRO.
Similar pacing-2a,-2b pacing will become, a national multi-center clinical study of consumers plan to undergo LASIK surgery. Participants will be followed up for at least 6 months after surgery.
The FDA is not receiving a proposal from the clinical center or accept applications from patients to search for prey-2b at this time. Additional information relating to prowl-2b will be posted to this website when available. Organization and Process
Questionnaire and the study protocol that was developed by a group of experts from government agencies to collaborate. In addition to specialists from the partnership of government, an independent body of authority are strictly selected subjects from a professional organization to review the protocol, including a questionnaire, and make recommendations. This independent agency with expertise in research design, statistical analysis, the measurement results of the reported patients, eye surgery and eye care. Two representative patients, one with good results and others with poor results following LASIK, is also part of group review of research protocols. Expected Project Benefits
The LQOLCP will help measure the outcomes of patients following LASIK and explore the factors that may affect them. The findings of the study is expected to help doctors and patients considering LASIK to make more informed decisions about the operation, could potentially lead to better results.
Please return to this site for future updates. - - Links on this page:

   1. / NewsEvents/Newsroom/PressAnnouncements/2010/ucm230139.htm
   2. https: / / secure.emmes.com / emmesweb / project / which provides
   3. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm
Page Last Updated: 28/03/2011 Note: If you need help accessing information in different file formats, see the Instructions for Downloading Viewe