Phase I of LASIK Quality of Life Study Begins

The Food and Drug Administration has launched a collaborative study with the National Eye Institute and the Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web-based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, FDA will evaluate whether any action is necessary. The project is part of the FDA's ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

"This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," said Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health.

FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics, and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The administration regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.

"Many people in the U.S. undergo LASIK procedures," Shuren said. "Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."

For more information, click here.

Download Center

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program.

  • Job Hazard Analysis Guide

    This guide includes details on how to conduct a thorough Job Hazard Analysis, and it's based directly on an OSHA publication for conducting JHAs. Learn how to identify potential hazards associated with each task of a job and set controls to mitigate hazard risks.

  • A Guide to Practicing “New Safety”

    Learn from safety professionals from around the world as they share their perspectives on various “new views” of safety, including Safety Differently, Safety-II, No Safety, Human and Organizational Performance (HOP), Resilience Engineering, and more in this helpful guide.

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • EHS Software Buyer's Guide

    Learn the keys to staying organized, staying sharp, and staying one step ahead on all things safety. This buyer’s guide is designed for you to use in your search for the safety management solution that best suits your company’s needs.

  • Vector Solutions

Featured Whitepaper

OH&S Digital Edition

  • OHS Magazine Digital Edition - July August 2022

    July / August 2022

    Featuring:

    • CONFINED SPACES
      Specific PPE is Needed for Entry and Exit
    • HAZARD COMMUNICATION
      Three Quick Steps to Better HazCom Training
    • GAS DETECTION
      Building a Chemical Emergency Toolkit
    • RESPIRATORY PROTECTION
      The Last Line of Defense
    View This Issue