Navigation Links
FDA Announces Plans for LASIK Quality of Life Project
Date:10/15/2009

Agency also Announces Warning Letters Issued to LASIK Facilities

SILVER SPRING, Md., Oct. 15 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. 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 excimer laser to permanently change the shape of the cornea.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

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 Webbased 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 related to the safety or effectiveness of the lasers used in LASIK surgery, the 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.

The 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.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA 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," said Shuren. "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:

The FDA's Web site on LASIK:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm

FDA Guidance: Medical Device Reporting for User Facilities:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095266.pdf

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov

Consumer Inquiries: 1-888-INFO-FDA

SOURCE U.S. Food and Drug Administration


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Cardium Announces $6.0 Million Registered Direct Offering
2. Elsevier announces launch of Spatial and Spatio-temporal Epidemiology
3. Managing Myeloma Website Announces Fellow Scholarship Program to Attend and Report on Annual American Society of Hematology in New Orleans
4. Beckman Coulter Announces Third Quarter 2009 Earnings to be Released on Thursday, October 29, 2009, After Market Closes
5. NBCU Announces New Company-Wide Initiative: Healthy At NBCU
6. Twinlab(R) Announces Winner of the 2009 RateYourAbs.com Contest
7. The National Association for Home Care & Hospice Announces the Completion of The BlackBerry Report - a Comprehensive Study on Technology and Home Care
8. Webcast Alert: Usinas Siderurgicas de Minas Gerais S.A. - USIMINAS Announces Third Quarter 2009 Results Webcast
9. Cardium Announces Commercial Development of Excellagen(TM) a Customized Collagen-Based Topical Gel for Initial Use as an Adjunct to Surgical Debridement in Patients With Diabetic Foot Ulcers
10. STEMCELL Technologies Inc. Announces Release of Defined, Animal-Protein Free Maintenance Medium for hESCs and hiPSCs
11. Conseco Announces Availability of Important Information on its Website
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... (PRWEB) , ... December 09, 2016 , ... ... Ball at The Pierre Hotel in New York, NY, on December 3rd, to ... dignitaries and physicians attended the annual event, which raised over $1 million - ...
(Date:12/8/2016)... WV (PRWEB) , ... December 08, 2016 , ... ... it will become Quality Insights beginning January 1, 2017. The name change ... its commitment to measuring and improving health care quality. , “We are very ...
(Date:12/8/2016)... ... 08, 2016 , ... ZyDoc , a New York-based ... Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study” ... comparative usability study demonstrate that a dictation-based method (“NLP Entry”) using ZyDoc’s MediSapien™ ...
(Date:12/8/2016)... ... 2016 , ... With the increasing demand for dental implants, the National Association ... to inform dentists and patients about the safety issues related to dental restorations. According ... the U.S. is projected to reach $6.4 billion in 2018 with more than 30 ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... continuity to its innovative Unified Instance Manager architecture, meeting the needs of ... new version optimizes the unattended auto-dialing system without agents, Presence Robodialer, provides ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... VIEW, Calif. , Dec. 8, 2016 IRIDEX ... intends to offer newly issued shares of common stock, $0.01 ... pursuant to an underwritten public offering.  The final terms of ... the time of pricing, and there can be no assurance ... IRIDEX expects to use the net proceeds it ...
(Date:12/8/2016)... Australia Glaucoma Surgery Devices Market Outlook ... "Australia Glaucoma Surgery Devices Market Outlook to 2022", ... Surgery Devices market. The report provides value, in ... average prices (USD) within market segement - Glaucoma ... shares and distribution shares data for each of ...
(Date:12/8/2016)... -- The global biosurgery market is expected to grow at ... 2016 to 2021. The market is poised to reach ... in 2016. The market is primarily driven by rising ... and spinal problems, increasing clearance of biosurgery products by ... management. In this report, the biosurgery market ...
Breaking Medicine Technology: