http://www.eurekalert.org/pub_releases/ ... 040708.php

Public release date: 7-Apr-2008
[ Print Article | E-mail Article | Close Window ]

Contact: John Ciccone
jciccone@ASCRS.org
703-975-7740
EluminatePR

ASCRS to participate in and co-fund study on post-lasik quality of life with US FDA

FDA reaffirms safety and efficacy; sees value in understanding diverse factors that comprise quality of life

CHICAGO, ASCRS Symposium and Congress, (April 7, 2008) – The American Society of Cataract and Refractive Surgery (ASCRS) today announced that it will participate in a post-LASIK quality of life study with the Joint LASIK Study Task Force, which includes the U.S. Food and Drug Administration (FDA), the National Eye Institute (NEI), ASCRS and the American Academy of Ophthalmology. ASCRS also announced that the ASCRS Foundation has committed funds to support this effort.

The FDA reaffirms that LASIK is both safe and effective. The Joint LASIK Study Task Force now will examine LASIK’S impact on the quality of patients’ daily lives. Simply defined, quality of life refers to a patient’s ability to perform the activities of daily living, everything from driving, daily routine, family life, career and sports performance, to personal appearance, after LASIK. While the FDA reports that nearly all patients are satisfied with their procedure, the study will seek to qualify LASIK’s benefits and provide greater understanding of the very few patients whose expectations are not met with the procedure, with the goal of identifying ways to enhance patient care.

“To date, there have been few studies that looked specifically at quality of life. Most have focused on patient satisfaction – which is extraordinarily high for LASIK – but satisfaction is just one component of quality of life,” said Kerry Solomon, MD, ASCRS co-chair of the

Joint LASIK Study Task Force and professor of ophthalmology, Medical University of South Carolina. “The study will give us invaluable insight on the many and diverse factors that make up quality of life. This new knowledge will ultimately be a great benefit to patients and doctors alike.”

Possible study outcomes could include a more holistic approach to patient screening and pre-operative patient counseling, with considerations for both physical and psychodynamic factors, as well as a better understanding of the myriad factors that comprise quality of life.

“The FDA deserves credit for orchestrating the Joint LASIK Study Task Force, and it has been a pleasure to work in concert with them, the National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO), to develop a study that will ensure patients get the most from America’s most-popular elective procedure,” said Richard L. Lindstrom, MD, co-chair of the Joint LASIK Study Task Force and immediate past president of the ASCRS. “When a procedure advances as far as LASIK has, both technologically and clinically, having a greater understanding of quality of life will help both patients and doctors, and could provide the next breakthrough in the procedure’s performance.”

Why Now

Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients. In 2006, the FDA re-evaluated symptoms and satisfaction data and reaffirmed that while the vast majority of LASIK patients were indeed satisfied with their outcomes, a few were not. In 2007, the Joint LASIK Study Task Force was formed to look into quality of life and the feasibility of a post-LASIK study. As part of this process, the FDA Ophthalmic Device Panel Medical Devices Advisory Committee will discuss post-market experience with both phakic intraocular lenses (phakic IOLs) and LASIK at its regularly scheduled April 24-25 meeting.

“People undergo LASIK to improve and enhance their quality of life. The LASIK procedure was designed specifically to improve patients’ quality of life, and it has with great success for millions of people. What we are looking to do is study people that are satisfied with their procedure vs. people who aren’t – even though this is a rare occasional patient. The more we can learn from that rare occasional patient, the better this procedure can be for everyone,” said Dr. Solomon.

LASIK World Literature Review: Quality of Life and Patient Satisfaction As part of this process, ASCRS set the task of reviewing information on satisfaction post-LASIK using a meta-analysis of the worldwide body of scientific literature on LASIK. Findings of the meta-analysis, announced last month, revealed a 95.4 percent patient satisfaction rate among LASIK patients worldwide.

"We found there is solid evidence in the world’s scientific literature to affirm an exceptionally high level of satisfaction in patients who have had LASIK surgery – 95.4% in fact," said Dr. Solomon. "Importantly, these rates have been consistent over the past 10 years."

Led by Dr. Solomon, the meta-analysis examined approximately 3,000 peer-reviewed articles published over the past 10 years in clinical journals from around the world. Of those, a subset of 19 studies, comprising 2,200 patients, looked directly at satisfaction. All studies referenced in the global review were peer-reviewed and the resulting meta-analysis itself has been submitted for publication in a peer-reviewed medical journal. Dr. Solomon will present findings from LASIK World Literature Review: Quality of Life and Patient Satisfaction at the ASCRS Symposium.


###
About LASIK

With almost two decades of innovation resulting in improved visual outcomes and one of the highest safety profiles of any elective procedure, Laser Assisted In-Situ Keratomileusis (LASIK) is the world's most-popular elective procedure available today. According to MarketScope, an average of 700,000 patients in the U.S. have LASIK annually to treat nearsightedness (myopia), farsightedness (hyperopia), the blurriness of astigmatism, and loss of reading vision (Presbyopia). To date, more than 28.3 million LASIK procedures have been performed worldwide MarketScope reports.

With more than a decade of clinical research, LASIK has been extensively studied. Collectively, 7,830 patients (representing 16,502 eyes) participated in clinical trials from 1993 – 2005. Advances in LASIK technology over the past decade have led to superior safety and better visual outcomes. The recent approval of modern LASIK for U.S. Air Force fighter pilots and NASA astronaut candidates is the procedure’s latest validation.

About The American Society of Cataract and Refractive Surgery

The mission of the ASCRS is to advance the art and science of ophthalmic surgery and the knowledge and skills of ophthalmic surgeons. It does so by providing clinical and practice management education and by working with patients, government, and the medical community to promote the delivery of quality eye care. ASCRS is holding its annual Symposium and Congress in Chicago, April 4-9, 2008. The society has 10,000 members worldwide.

http://www.youtube.com/watch?v=VpwcF3Malj8

http://www.youtube.com/watch?v=jQUNk5meJHs&NR=1

http://www.youtube.com/watch?v=jy8b6Qeh ... re=related

From another perspective:

http://www.chron.com/disp/story.mpl/ap/fn/5681452.html

http://www.osnsupersite.com/view.asp?rid=27476

OSN SuperSite Top Story 4/8/2008

ASCRS to co-fund, participate in LASIK quality-of-life study

CHICAGO — The American Society of Cataract and Refractive Surgery committed funds to and will participate in a study on quality of life after LASIK to be conducted jointly with the American Academy of Ophthalmology, the U.S. Food and Drug Administration and the National Eye Institute, the society announced here.

"Today, while we reaffirm the safety and effectiveness of LASIK, we are pleased to announce that ASCRS will participate in and co-fund a study on the impact of LASIK on quality of life," said Richard L. Lindstrom, MD, Chief Medical Editor of Ocular Surgery News, immediate past president of ASCRS and co-chair of the ASCRS task force on LASIK.

"Every one of the four sponsors has committed significant volunteer and/or employee resources. The FDA has committed dollars to this, and at this meeting, the ASCRS executive committee and the foundation board did commit to co-fund the study," he explained.

Dr. Lindstrom said that they did not currently have a specific monetary amount as the cost of the study has not yet been determined. He was joined by Kerry D. Solomon, MD, co-chair of the task force, and Steven C. Schallhorn, MD, who is the chairman of the protocol development committee for the proposed study.

Dr. Schallhorn explained that the study is still under evaluation, but that the four co-sponsors have agreed on the fundamentals of having a large, multicenter, prospective study. The current objectives are to reconfirm the 95% satisfaction rate shown by Dr. Solomon's meta-analysis of published literature; to determine changes in the quality of life; and to further understand what contributes to satisfaction or dissatisfaction, he said.

"I think it's important that there's an appreciation that what we're talking about here is not the safety and effectiveness of LASIK. That has never been an issue," Dr. Schallhorn said. "The confines of the study are really dealing with the quality-of-life issues and especially the quality-of-life issues in those few patients who are dissatisfied."

Dr. Solomon and Dr. Schallhorn explained that many factors contribute to dissatisfaction with LASIK, many of which are present before the patient's procedure, such as dry eye, night vision symptoms and psychological tendencies.

"Our goal as physicians is to put patients first and to try to continue to improve this procedure. We're always trying to make the procedure better because that's in the best interest of our patients, and the more we learn about this procedure, the more we can help those very few patients who may be dissatisfied or unhappy," Dr. Solomon said. "Our short-term and long-term goals are to improve LASIK satisfaction to 99% or higher and minimize or eliminate patient dissatisfaction."

Dr. Lindstrom said that the society has submitted to the FDA the names of himself, Dr. Schallhorn, Dr. Solomon, David J. Tanzer, MD, and Peter J. McDonnell, MD, to speak at the upcoming meeting of the FDA Ophthalmic Devices Panel of the Medical Devices Advisory Committee on April 24 and 25.

At the meeting, Dr. Schallhorn will be representing the AAO, and Dr. McDonnell will be representing the International Society of Refractive Surgery.

"I believe that the primary patient advocate, worldwide, is the physician and surgeon, and representing 10,000 ophthalmic surgeons worldwide, I believe this study is consistent with our mission," Dr. Lindstrom said.

Do any of these doctors have a vested interest with a laser manufacturer?

Also, how does one participate in this study?

From the April 25 FDA hearing transcript:

There's no such thing as a LASIK surgeon with no financial interest in the LASIK procedure. The industry is deliberately misleading the public by performing a 'quality of life' study when the technology to measure visual quality and ocular health are readily available.

Why not quantitatively measure visual quality? ANSWER - because visual quality is systematically decreased by LASIK.

And LASIK consistenly induces dry eye. Why not correlate decrease in visual quality and objective measures of dry eye with quality of life? If the industry were seeking real associations between quality of life and LASIK, that would be the study to conduct - clearly.

http://www.krounerlaw.com/images/FDAletter042508.pdf

http://www.crstodayeurope.com/Issues/0608/0608_14.pdf



1. Larkin C. LASIK study is a priority in US, will start by 2009. Bloomberg News. Available at:
http://www.bloomberg.com/apps/news?pid= ... 6SKlifKQvU
Accessed
on May 22, 2008.

http://health.usnews.com/usnews/health/ ... urgery.htm

They have to study new patients in order to cover up the complaints of existing victims. If they studied existing victims, LASIK would immediately fold and there would be a massive congressional investigation.