http://www.osnsupersite.com/view.asp?rid=27019

OSN SuperSite Top Story 3/17/2008

Ophthalmic organizations, government agencies join forces to discuss clinical trial for dissatisfied LASIK patients

SAN FRANCISCO — The American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology, in conjunction with the U.S. Food and Drug Administration and the National Eye Institute, have assembled a joint task force charged with formulating a viable study design to identify dissatisfied post-LASIK patients, define their significant symptoms and evaluate the influence of those symptoms on quality of life, according to a joint press release from ASCRS and AAO.

The collaboration marks the first time that the FDA has called for counsel from external organizations concerning the design of such a study, the release said.

"We are pleased to have this opportunity to collaborate with the FDA and NEI on designing the study," ASCRS president, joint task force chair and Ocular Surgery News Chief Medical Editor Richard L. Lindstrom, MD, said in the release. "ASCRS and the Academy will rely upon the best interests of patients, scientific validity and transparency to guide their actions through this process."

Encouraged by FDA petitions urging for an effective freeze on nonessential eye surgeries, the FDA initially approached ASCRS in fall 2006 for assistance in designing the post-LASIK quality-of-life trial. Although the FDA did not deem the majority of requests worthy of new investigation, the agency has permitted the petitioners to present testimony at a special meeting of the Ophthalmic Devices Panel scheduled for April.

During the meeting, delegates from the Ophthalmic Devices Panel will review concerns related to poor outcomes after LASIK and implantation of phakic IOLs, and consider their effects on patients' quality-of-life, according to the release.

In addition, the ASCRS has launched a meta-analysis of the global literature regarding patient-reported outcomes and quality of life after LASIK. Task force member and study director Kerry D. Solomon, MD, is scheduled to report the results at the 2008 ASCRS-ASOA Annual Symposium and Congress in Chicago.

The joint task force has not yet made a final decision regarding the necessity and design of the study.

"Ultimately, joint task force recommendations will be put to the governing boards of the ASCRS and AAO to consider. Then, it will fall to the regulatory agencies to determine what, if any, steps need to be taken," the release said.

VSRN has requested to be placed on the list of presenters at this public meeting. It would appear that presentations will be limited to about five minutes, due to the anticipated number of people requesting to be heard.

Hi Barbara and Doc,

I heard on the radio that there was going to be something on the FDA website where you could take a survey on your LASIK experience, but I was on the site recently and didn't find anything of the sort. Do you know if this is something they're planning for the future?

Thanks,

chris

I am unaware of such a survey. A task force has been established to study quality of life after LASIK, but it consists of the FDA, the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology, and the U.S. National Eye Institute. Unfortunately, there are too many vested interests there, and it seems a bit like setting the fox to guard the henhouse.

The FDA will eventually publish all of the testimony and written comments submitted for the April 25 meeting on their Web site. To the best of my knowledge, no survey is being made available to the general public. If anyone has information indicating otherwise, please let me know.

Hi Barbara,

Well, I guess what I heard was reference to reporting a general problem to the FDA.

http://www.npr.org/templates/story/story.php?storyId=90070220

https://www.accessdata.fda.gov/scripts/medwatch/

I'm going to submit my complaints. I suppose this is where we could increase the number of complaints from 140 to something much larger.

I urge everyone with a problem following LASIK to file a complaint with the FDA. Go to medwatch online reporting form. Fill out the forms as completely as possible. The more complaints they get, the more likely they will be to pay us some attention. The actual URL for that link is: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm