FDA To Investigate Quality Of Life Problems Following LASIK Eye Surgery

Featured Article
Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 16 Oct 2009 - 11:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

The US Food and Drug Administration has launched a collaborative study to investigate the potential impact of Laser-Assisted In Situ Keratomileusis (LASIK) eye surgery on patients' quality of life. The project will seek to establish the proportion of LASIK patients in the US who experience significant post-procedure quality of life problems such as blurred vision and dry eyes.

The FDA announced the launch of the LASIK Quality of Life Collaboration Project on Thursday. The agency will be collaborating with the National Eye Institute and the US Department of Defense.

LASIK is a surgical procedure that uses a laser to permanently change the shape of the cornea, the transparent tissue of the eye that sits in front of the iris and pupil. Many people have the surgery so they don't have to wear contact lenses or eye glasses.

The federal agency also announced that it had sent warning letters to 17 ambulatory LASIK surgery centers after inspections showed their adverse event reporting systems were inadequate. The FDA stressed that the inspectors did not find problems with the equipment, it was the way the centers were collecting and reporting adverse events that was the problem.

Dr Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health told the media that many Americans undergo LASIK surgery, and that:

"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," he added.

The FDA announcement said that the results of the LASIK Quality of Life Collaboration 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".

The agency said if they find that any of the factors are linked to the safety or effectiveness of the laser equipment, they will then evaluate if any action is necessary.

"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 Shuren.

The project will have three phases: Phase 1 started in July 2009 and will result in the design of a web-based quality of life questionnaire. Phase 2 will assess quality of life and satisfaction with LASIK in a select active duty population treated at the Navy Refractive Surgery Center; and Phase 3, which is expected to finish in 2012, will study the impact of LASIK on quality of life in the general population by means of a national multi-center clinical trial.

TLC Vision, one of North America's largest providers of eye care services, responded to the FDA announcement about the warning letters in a press statement released on Friday.

The company's president and CEO, James B Tiffany told the press that:

"Over the course of the last 4 months, six TLCVision refractive surgery centers were inspected by the FDA. This was a limited, directed inspection and assessment of the firm's compliance with statutory reporting requirements."

He said the company is seeking clarification from the FDA about the warning letters: he stressed that the agency investigators:

"Issued no objectionable or adverse findings at the centers in which we received their establishment inspection reports."

"One center was noted to need additional written procedures as outlined in a letter received from the FDA on August 20, 2009. On September 4, 2009, we responded to the FDA that we have already begun the process to enhance our existing reporting procedures in that center," explained Tiffany.

He reiterated the FDA's message that neither the inspections nor the observations mentioned problems with equipment safety and effectiveness.

Source: FDA, TLC Vision.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today