Navigation Links
New FDA Study Seeks Feedback on Lasik Surgery
Date:10/16/2009

Warnings issued to 17 centers for lax reporting of procedure-related adverse events

FRIDAY, Oct. 16 (HealthDay News) -- The percentage of patients who experience serious quality-of-life problems after Lasik eye surgery is being studied by the U.S. Food and Drug Administration, which has also issued warning letters to a number of Lasik facilities that weren't properly reporting problems with the procedure.

The FDA study, which will also identify factors that predict quality-of-life problems in Lasik patients, has three phases. Phase 1, launched in July 2009, involves the design and launch of a Web-based questionnaire to assess patient-reported outcomes and evaluate quality-of-life issues after the laser-assisted eye surgery.

Phase 2 will examine quality of life and satisfaction among patients treated at the Navy Refractive Surgery Center, and phase 3 will be a national, multi-center clinical trial to study quality of life after Lasik among the general population.

"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," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said in an agency news release.

If the study identifies any problems with the safety or effectiveness of the lasers used in Lasik surgery, the agency will evaluate whether any action is necessary.

In related news, the FDA also noted in the release that it issued warning letters to 17 Lasik ambulatory surgical centers after inspections revealed that the centers had inadequate systems for reporting problems suffered by patients. The types of problems were specified.

"Many people in the U.S. undergo Lasik procedures. Ambulatory surgical centers that perform Lasik must maintain a robust reporting system as required by law," Shuren said in the news release. "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."

More information

The FDA has more about Lasik eye surgery.



-- Robert Preidt



SOURCE: U.S. Food and Drug Administration, news release, Oct. 15, 2009


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... ... May 24, 2016 , ... ... and clinical practice of radiosurgery, is recognizing five medical residents and students for ... stereotactic body radiotherapy (SBRT). The awards will be presented at the 2016 SRS/SBRT ...
(Date:5/24/2016)... ... 24, 2016 , ... Tuesday, May 24, Women's Excellence in Wellness, powered by ... Living Essential Oils, taught by Patti Dolan, RYT, a Young Living Gold Member. ... is 6:30pm - 7:15pm followed by a small intro to the Oils that can ...
(Date:5/24/2016)... ... ... WaterAid launched the #perioddrama campaign to mark Menstrual Hygiene Day on May 28 and ... who do not have access to a toilet, even when they’re on their periods. , ... The (sometimes hilarious) results help shine a light on the awkwardness that women face while ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... ... trip to the Dominican Republic on September 21, 2016. Dr. Gerard, who holds ... serves with ChiroMission, a not-for-profit organization promoting health and wellness in Third World ...
(Date:5/24/2016)... , ... May 24, 2016 , ... The Dream Builders ... supplies and other necessities to Eunime Orphanage in Tijuana, Mexico on Saturday, May 21st. ... games at Peter Piper Pizza. , More than 15 volunteers traveled from Los ...
Breaking Medicine News(10 mins):
(Date:5/20/2016)... , May 20, 2016 The ... investors believe that the industry is not far from ... today ActiveWallSt.com featured the following four equities: Anacor Pharmaceuticals ... ATHX ), Aralez Pharmaceuticals Inc. (NASDAQ: ... INFI ). Sign up for your free trading ...
(Date:5/19/2016)... , May 19,2016 Cellvizio ... Digestive Disease Week Meeting and 91 st ... Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) ... platform, today announced that its Cellvizio platform is ... on gastroenterology during the month of May. The ...
(Date:5/19/2016)... , The data will be presented in ... The conclusions of the study point to a ... 90% of the m presenting duration ... of the patients had clinical benefit.     ... study of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed ...
Breaking Medicine Technology: