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FDA panel scrutinizes LASIK safety data
While the advisory panel offered no sweeping changes, it made recommendations to update FDA labeling information on the procedure.
GAITHERSBURG, Md. – Issues surrounding patient safety, patient satisfaction and even marketing practices associated with LASIK came under intense scrutiny since the U.S. Food and Drug Administration Ophthalmic Devices Panel heard public testimony in April in favor of and sometimes vehemently opposed to the surgery.
 Jayne S. Weiss, MD, chair of the FDA Ophthalmic Devices Panel, is involved in the FDA’s review of LASIK safety data. | ||
Based in part on the testimony and the passage of time since labeling information was last reviewed, the panel made recommendations to update labeling information as well as its own patient information Web site.
Despite some dramatic testimony at the April 25 meeting, the panel was not a “referendum on LASIK,” according to Jayne S. Weiss, MD, who chairs the FDA Ophthalmic Devices Panel.
“It appears to me from hearing what was said today that this really has been a referendum on the performance of LASIK by some surgeons who should be doing a better job,” Dr. Weiss said.
The Ophthalmic Devices Panel heard a number of impassioned presentations opposing LASIK. The testimony came from individuals who had suffered adverse LASIK-related complications, therapists and other specialists who had treated patients for depression after adverse complications, optometrists, ophthalmologists and attorneys representing those patients.
Some patients commented on the proposed quality-of-life study to be conducted in 2009 by the FDA, the National Eye Institute, the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology. The announcement of the prospective study comes on the heels of syndicated reports in recent months of depression and suicide of patients after LASIK.
Strong calls for change
Todd J. Krouner, JD, argued that the FDA quality-of-life study be carried out independent of the refractive surgery industry, which he sees as embodied in the ASCRS and AAO.
Mr. Krouner, a LASIK malpractice attorney based in Chappaqua, N.Y., said, “Given the self-interest of the LASIK industry and its surgeons, it is respectfully submitted that any review of LASIK safety, satisfaction or study of correlation between bad LASIK outcomes and suicide should not be delegated exclusively to those who have a vested interest in the conclusion.”
Matt Kotsovolos, former chief financial officer of Duke Eye Center in Durham, N.C., went even further, calling upon the FDA to impose a moratorium on LASIK procedures until more is known about the alleged psychological damage inflicted upon those who have experienced debilitating complications.
Mr. Kotsovolos argued that although the LASIK industry quotes complications rates of 1% to 3%, the real numbers are much closer to 20% to 30%.
“Patients do not want to continue to exist as helpless victims with no solutions and no voice. … I urge the FDA advisory panel to recommend placing a moratorium on LASIK until a proper comprehensive study of long-term LASIK complications and symptoms, including clinical depression, is completed,” he said.
Malvina Eydelman, MD, director of the Division of Ophthalmic and Ear, Nose and Throat Devices at the FDA, defended the yet-to-be-conducted study at another point in the meeting, saying, “I can assure you that every precaution is being taken to eliminate potential conflicts of interest. This study will be conducted in accordance with the regulations governing FDA and NEI clinical trials.”
Painful stories from poor outcomes
Much of the public testimony offered against LASIK concerned personal stories of depression, suicide or suicidal ideation and other psychological problems resulting from adverse LASIK outcomes.
Gerard Dorrian talked about his son Colin, who had LASIK as a law student at the University of Michigan. According to Mr. Dorrian, Colin had become intolerant of contact lenses due to dry eye. Mr. Dorrian said Colin suffered painful chronic dry eye after LASIK and committed suicide 6 years after the procedure. He read from a letter that his son wrote, which read, in part, “I cannot accept the fact I have to live like this. I am rotting from the inside out.”
The panel also heard a presentation from Edward L. Boshnick, OD, who, according to the EyeFreedom.com Web site, specializes in “restoration of vision and comfort lost as a result of refractive eye surgery, keratoconus, pellucid marginal degeneration, extreme dry eye, corneal dystrophies, corneal trauma and Stevens-Johnson syndrome.”
Dr. Boshnick said he has cared for several hundred post-LASIK patients and has seen the devastating effects of those in pain from vision disturbances associated with LASIK. However, he cautioned that because of the nature of his practice, he does not see “happy post-LASIK” patients.
Data support LASIK benefits, safety
Negative opinions and LASIK complication horror stories were not the only component to the public testimony at the meeting. Several speakers presented a large body of scientific evidence that showed the benefits of LASIK and high patient satisfaction rates.
 Kerry D. Solomon |
OSN Refractive Surgery Section Member Kerry D. Solomon, MD, spoke about the worldwide retrospective literature review of LASIK that found a 95.4% patient satisfaction rate from post-LASIK patients.
OSN Cornea/External Disease Section Editor Eric D. Donnenfeld, MD, presented for the first time a separate worldwide retrospective review that the task force conducted analyzing dry eye after LASIK.
In a meta-analysis of more than 1,000 articles, the task force found reviewable data from 46 peer-review articles published in 13 journals from 15 countries and covering more than 32,000 eyes. Dr. Donnenfeld and colleagues found that although dry eye is common after LASIK (35% of patients), 32% of those same patients had pre-existing dry eye.
“The great majority of patients had complete resolution of their dry eye symptoms over a 2- to 4-week period following surgery,” Dr. Donnenfeld said. “Severe dry eye following LASIK is extremely rare.”
The military experience
Some of the strongest evidence and testimony in support of LASIK came from reports from the U.S. military’s experience with LASIK.
 Scott Barnes |
Previously trained in the Special Forces before becoming an eye surgeon, Lt. Col. Scott Barnes, MD, from Fort Bragg, N.C., described how commanders in the Special Forces asked him to evaluate laser vision correction specifically for those Special Forces soldiers.
Since that time, Dr. Barnes said, the Special Forces troops have come to rely on laser vision correction to help them on the battlefield.
“It’s a significant issue for these guys,” he said. “They’re not talking about cosmetic needs. They’re saying, ‘I can’t do my job as well in glasses or contacts as I can after refractive surgery.’”
Cmdr. David Tanzer, MD, of the Navy, who was invited to speak by the FDA panel, cited a number of studies such as the flap stability study that found no flap dislocations occurred in an animal model with a force equivalent to either halo jumps, which are freefall parachute jumps from airplanes at high altitude, or forced ejections of pilots from airplanes.
“There have been 45 studies performed to date by the Department of Defense,” he said. “Our goal is the constant, independent evaluation of the safety and efficacy of laser vision correction.”
To date, there has only been one military medical disability retirement due to complications related to laser vision correction, which would equate with a 0.009% incidence in the military, he said.
Panel reacts
The FDA panel commented on the diversity of opinions represented at the forum.
“I think we have heard here today there are two different animals here,” Dr. Weiss said. “We have those patients who come in the next day who are filled with elation … and they are very happy patients, and then we have those people who have been reported to us today, who have visually disabling starbursts and halos. I think we need to start, if we are not already, distinguishing between the side effects that disappear and the complications.”
According to Dr. Weiss, there were a number of disturbing issues raised during the meeting that fell outside of the purview of the FDA that should be addressed in other forums, including overly aggressive marketing, portraying LASIK as a commodity, the lack of informed consent in some cases and inadequate patient screening procedures.
Recommended labeling changes
The panel made a number of recommendations for changes to patient labeling as well as for the FDA Web site page on LASIK.
The panel agreed that post-LASIK patients who go on to have cataract surgery should have IOP monitoring. There should also be an indication that LASIK affects IOL implant measurements. Several photos should be used to distinguish how vision appears when affected by halos, starbursts or glare. The panel also recommended, if not present already, there be sufficiently strongly worded caution for patients with keratoconus and other ectatic disorders.
The panel also advocated distinguishing between those with collagen vascular disease vs. those with collagen vascular disease with dry eye. Dr. Weiss said some wording could be included to point out possible psychological implications of adverse LASIK outcomes.
Surgeons recognize warning
In an interview with Ocular Surgery News, Chief Medical Editor Richard L. Lindstrom, MD, who was not present at the panel meeting, but who co-chairs the joint LASIK study task force with Dr. Solomon, said, “The dissatisfied patient is a real concern for the LASIK surgeon, organized ophthalmology as a whole and the industry that supports this procedure.
“It is important for the dissatisfied LASIK patient to know that we, the LASIK surgeons, are listening, that we hear them, that we care, and that we are responding in a tangible and constructive fashion,” Dr. Lindstrom said.
The Prospective Evaluation of LASIK Satisfaction (PELS) study will provide insights into the incidences, causes and treatment of patient dissatisfaction from LASIK, he noted.
“The study will allow enhanced patient education and counseling and improve patient selection and treatment, increasing patient satisfaction rates to even higher levels,” he said.
Drs. Solomon and Donnenfeld discussed with OSN what they took away from this meeting and how it would affect refractive practices.
“If that rare occasional thing should occur where someone is dissatisfied, we as physicians need to spend the time with that patient to make them understand we are in this together. … What I did hear [at the panel] was that some of these patients felt like they were abandoned,” Dr. Solomon said.
Dr. Donnenfeld also stressed the need to care for dissatisfied patients.
“While LASIK is the safest elective procedure ever, we as ophthalmologists cannot rest until every patient has as good a result as possible and every complication is eliminated,” he said.
For more information:
- Lt. Col. Scott Barnes, MD, can be reached at LTC Scott Barnes, WRESP, Womack Army Medical Center, Fort Bragg, NC 28310; e-mail: scott.d.barnes@us.army.mil.
- Edward L. Boshnick, OD, can be reached at 8479 Coral Way, Miami, FL 33155; 305-264-4400; e-mail: dredbosh@comcast.net; Web site: eyefreedom.com.
- Eric D. Donnenfeld, MD, can be reached at OCLI, 2000 N. Village Ave. Suite 402, Rockville Centre, NY 11570; 516-766-2519; fax: 516-766-3714; e-mail: eddoph@aol.com.
- Malvina Eydelman, MD, can be reached at the Division of Ophthalmic and ENT Devices, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850; e-mail: malvina.eydelman@fda.hhs.gov.
- Todd J. Krouner, JD, can be reached at 93 N. Greeley Ave., Suite 100, Chappaqua, NY 10514; 914-238-5800; e-mail: info@krounerlaw.com.
- Kerry D. Solomon, MD, can be reached at the Medical University of South Carolina, Storm Eye Institute, 167 Ashley Ave., Room 221, PO Box 250676, Charleston, SC 29425; 843-792-8854; fax: 843-792-6347; e-mail: solomonk@musc.edu.
- Cmdr. David J. Tanzer, MD, can be reached at the Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92135; 619-532-6700; e-mail: david.tanzer@med.navy.mil.
- Jayne S. Weiss, MD, can be reached at Kresge Eye Institute, University Eye Physicians, 4717 St. Antoine, Detroit, MI 48201-1423; 313-577-2964; fax: 313-577-5099; e-mail: jweiss@med.wayne.edu.
- David W. Mullin is Executive Editor of the international editions of OSN.