FDA poised to re-examine LASIK safety, postop patient satisfaction

As burgeoning technological developments and reports of high patient satisfaction rates support LASIK as a safe and effective procedure, the surgery is undergoing renewed scrutiny amid concerns about safety and postop quality of life.

The U.S. Food and Drug Administration recently embarked on the most thorough review of LASIK since the surgery first passed muster in FDA clinical trials more than a decade ago. In addition, the handling of data on complications and patient satisfaction has become a bone of contention between a former FDA official and a surgeon-advocate.

As clinicians and investigators take pause and re-examine LASIK, it maintains its position as the leading refractive surgical procedure globally. Whether it continues to hold that status may hinge, at least in part, on the results of the FDA study.

Refractive surgeons are aware of potential complications and take exhaustive measures to prevent them.

Richard J. Duffey, MD, says that successful outcomes for LASIK hinge on the right combination of patient eligibility and surgeon experience. Image: Ketchum D

“My experience has been that LASIK has always been a very successful procedure,” Eric D. Donnenfeld, MD, OSN Cornea/External Disease Board Member, said. “But any surgical procedure has risks associated with it. These risks are minimized with a thorough preoperative evaluation and excellent treatment.”

Daniel S. Durrie, MD, OSN Refractive Surgery Section Editor, echoed Dr. Donnenfeld’s assessment.

“If somebody’s not a good candidate, we don’t operate on them,” Dr. Durrie said, noting that patients should be assured that they are good candidates for refractive surgery.

To date, about 20 million laser vision correction procedures have been performed worldwide with good results and a small percentage of complications, Dr. Durrie said.

“It is the most popular elective surgical procedure in the world,” he said. “Because the FDA is doing another study, that doesn’t mean that the procedure hasn’t passed the test of time.”

Outcomes hinge on the right combination of patient eligibility and surgeon experience, Richard J. Duffey, MD, OSN Refractive Surgery Board Member, said.

Daniel S. Durrie

“If you pick the right patients and combine them with the right technology and surgeons who are top-notch at what they do, laser vision correction is the platinum standard for modern medicine,” Dr. Duffey said.

FDA hearing on LASIK safety

The FDA’s focus on LASIK safety and outcomes gained momentum on the heels of a public hearing that the agency’s Ophthalmic Devices Panel held in April 2008.

Testimony at the hearing ran the gamut from impassioned opposition to LASIK to ringing endorsements of the surgery. Some experts testified about patients being treated for depression related to postoperative complications. One report involved the suicide of a patient who was distraught over a debilitating visual outcome.

“There were several patients who were unhappy with the procedure,” Dr. Donnenfeld said. “The majority of the patients who were unhappy had concerns. These concerns included the fact that their complaints were not taken seriously. Some were complaining of dry eye. Some were complaining of glare and halo. Some were complaining of depression. These complaints were listened to and taken very seriously.”

The panel recommended changes to patient labeling and the FDA’s website on LASIK.

Debate on review process

In May 2010, Morris Waxler, PhD, a medical researcher and former FDA official who oversaw the evaluation of LASIK and PRK between 1996 and 2000, wrote a letter to R. Doyle Stulting,MD, PhD, president of the American Society of Cataract and Refractive Surgery, stating that the FDA, ASCRS, LASIK manufacturers and other stakeholders were “complicit” in downplaying permanent complications after LASIK.

R. Doyle Stulting

Several refractive surgeons have said that follow-up data were missing from clinical trial records and published literature because patients were satisfied with outcomes and saw no need for follow-up office visits, Dr. Waxler said.

“Honestly, that’s just not the case,” he said. “They didn’t come back in because they were angry at the refractive surgeons and felt that they could not go back and have any expectation that they would be served properly.”

Dr. Waxler said the published literature and data submitted by manufacturers demonstrate that LASIK-induced dry eye persists for more than 12 months. About 20% of LASIK patients have an increase in dry eyes that persists for more than 1 year, he said.

“The process is that you’re cutting the nerve fibers, and those nerve fibers essentially don’t regenerate,” he said. “If they do, they don’t regenerate in a very orderly fashion, so they cause pain and other kinds of surface problems.”

In his letter, Dr. Waxler also said that keratectasia would occur in more than 3,000 patients in 2010, a rate of 0.87 of about 700,000 LASIK surgeries expected to be done that year.

In a written response to Dr. Waxler in September 2010, Dr. Stulting termed Dr. Waxler’s estimate of keratectasia rates “inflated and inconsistent with existing data.” Published keratectasia rates range from 0.0004% to 0.66%, Dr. Stulting wrote.

Dr. Stulting, an OSN Cornea/External Disease Board Member, said Dr. Waxler’s numbers are not supported by the published literature. He also questioned Dr. Waxler’s definition of “complications.”

“Some of the symptoms Dr. Waxler labels as complications of LASIK are symptoms that were present before LASIK, transient, not significantly bothersome to be considered ‘complications,’ or symptoms that would have also been present with contact lens wear,” Dr. Stulting said. “He’s lumping all of those things together and making them appear to be induced by the laser, troublesome and permanent, but that’s not necessarily the case.”

Overall, it is unlikely that the FDA or other entities mishandled or misconstrued complication data, given the intensity of oversight and monitoring by the FDA and third parties, Dr. Stulting said.

“FDA clinical trials are very well-controlled,” he said. “They are done with protocols that are constructed before the initiation of the trial and approved by the FDA. They are monitored by third parties for accuracy. They are audited. They are about as reliable as we can possibly get.”

Quality-of-life study

The LASIK Quality of Life Collaboration Project, sponsored by the FDA, National Eye Institute and U.S. Department of Defense, is being conducted in three phases. The first phase, launched in July 2009, involves the design and implementation of a Web-based instrument such as a questionnaire to assess LASIK outcomes and postop quality of life.

The second phase will evaluate quality of life after LASIK and patient satisfaction reported by active duty personnel treated at the U.S. Navy Refractive Surgery Center in San Diego.

The third phase will be a national, multicenter clinical trial designed to assess quality of life after LASIK in a civilian patient sample.

Dr. Durrie voiced general support for the FDA’s desire to seek new data on patient satisfaction, despite the abundance of already available data.

“If they want to do that, it’s appropriate if they want to answer their own questions,” Dr. Durrie said. “But the marketplace, patients and surgeons have felt that this has been the most studied procedure of any procedure that has gone through the FDA.”

Dr. Duffey said the study is an effort to provide thorough and transparent data on LASIK.

“I have absolutely no problem with shining the sun on anything we do,” Dr. Duffey said. “That is the best way to find out what’s effective and what’s not. Publicity that is fair, that is balanced and really looks at satisfaction rates and complication rates in the long run will only benefit laser vision correction and vindicate the success that it has had over the last 15 years in the United States.”

Dr. Stulting said that the FDA should have researched complaints from unhappy LASIK patients in detail before investing valuable resources in a large study. He said it is clear that the incidence of poor outcomes is very small, as confirmed by the difficulties the FDA had in finding people who were unhappy with the surgery.

“The FDA should ask those who have been so vocal about complications of LASIK to make their medical records available to the FDA and LASIK surgeons so that we can see whether these complaints are actually due to LASIK and, if so, whether they could have been avoided in the past or future,” he said. “The most effective way to learn about LASIK complications is to focus on patients who have them.”

Dr. Stulting also noted that the FDA has refused to make its study protocol available for public comment before implementation. He said there are many advantages, and no disadvantages, in soliciting public comment to make sure the study is appropriately designed; he also objects to the expenditure of tax dollars on what he called a “secret” study.

Nevertheless, Dr. Stulting said he believes the study will corroborate existing data, indicating that the procedure is safe and effective. Like other surgical procedures and nonsurgical methods of vision correction — contact lenses, for example — LASIK is not free of complications and risks.

“Our job,” Dr. Stulting said, “is to educate our patients about the options for vision correction and allow them to choose LASIK, if they are comfortable with the potential risks and benefits.”

Dr. Waxler objected to the study on the grounds that it is not necessary, given the pure volume of existing data.

“There is no need to put additional folks at risk to demonstrate what is already known in the open literature,” Dr. Waxler said. “Some of the folks that are running that study are refractive surgeons who have a stake in the outcome. There is no way of getting around that. … They’re not thinking clearly and looking at the data that are already in front of them.”

Global review of data

A worldwide literature review, published in Ophthalmology in April 2009, reported a cumulative patient satisfaction rate of 95.4% among LASIK patients. Data were culled from 309 journal articles published around the world between 1988 and 2008.

“The most important take-home message from that study was that 95% of the patients were happy with the results following LASIK,” Dr. Donnenfeld said.

Dr. Durrie said that, if anything, the patient satisfaction data published in the study have been exceeded by more recent findings because of ongoing improvements in technology and protocols.

“You have to remember that the meta-analysis was done on published papers, which makes them significantly older than the technology that we’re using now,” Dr. Durrie said. “I think it underestimates the satisfaction of the procedures. On more recent studies that have been done, the satisfaction is still in the high-90% range, but it tends to have 97%, 98%, 99% of patients being satisfied.”

Dr. Waxler disputed the patient satisfaction rates reported in the world literature review.

“Frankly, the patient satisfaction measure is a dodge because the refractive surgeons and the manufacturers knew, and I was at meetings where this was discussed, that the reports from patients were showing consistently dry eye, night driving problems and halos, and they were discomfited by that,” Dr. Waxler said. “Then, they wanted to switch to something that would be a little more global and give them a better hook on the supposed comfort of the patient. So, they shifted to patient satisfaction.”

LASIK vs. alternatives

The 2010 AAO/International Society of Refractive Surgeons survey on U.S. trends in refractive surgery, presented in October 2010 at the AAO meeting in Chicago, showed an increase in the percentage of PRK procedures being performed in lieu of LASIK.

“I don’t think it’s because of the bad press [on LASIK],” Dr. Duffey said. “I think it’s because we have become more conservative as a group trying to prevent the worst complication, that being ectasia. So, we’re going to tend to be more conservative if we have borderline cases that perhaps in the past we would have done LASIK on and now do PRK.”

Dr. Duffey said that PRK currently comprises 15% of laser refractive procedures performed in his practice, up from 3% to 5% just a few years ago.

The survey results showed that 33% of surgeons would perform LASIK on a 30-year-old patient with 10 D of myopia and 15% of them would perform PRK.

“How many would do a phakic IOL? Forty percent,” Dr. Duffey said. “So, more surgeons would do laser vision correction on that 10 D myope, all things being equal, than a phakic intraocular lens. I think the reason for that is that one is an extraocular procedure, where the risks are lower, and one is an intraocular procedure, where the risks are higher.”

Similarly, for a 45-year-old patient with 3 D of hyperopia, 77% of surgeons responded that they would perform laser vision correction: 60% LASIK and 17% surface ablation. Seventeen percent of surgeons said they would perform a refractive lens exchange (RLE).

“Again, it’s the same mentality right there, that laser vision correction is going to be safer, at least for that degree of hyperopia,” Dr. Duffey said.

However, when surgeons were asked which procedure they would perform on a 45-year-old patient with 5 D of hyperopia, 62% favored RLE and 13% preferred laser vision correction: 9% LASIK and 4% PRK.

“The reason being that a refractive lens exchange in a hyperope is less risk than a refractive lens exchange in a high myope,” Dr. Duffey said. “And laser vision correction works better on low hyperopes but does not work as well on high hyperopes. It all follows what are the most successful and least risky procedures out there.”

Although there are no FDA-mandated limits on the degree of myopia that may be treated with laser surgery, many surgeons are reluctant to attempt the correction of more than 10 D to 12 D of myopia.

The FDA allows laser correction of up to 6 D of hyperopia, Dr. Duffey said.

“Most of us are pretty shy about doing it above 3 D to 4 D because the success rate really drops off,” he said. “The quality of vision in hyperopic patients and the regression rates are such that when you get more than about 3.5 D to 4 D, the results are not as good in hyperopia as they are in those degrees of myopia.”

LASIK, performed on well-qualified patients, has inherently less risk because of its extraocular nature than intraocular procedures such as RLE or phakic IOL insertion, Dr. Duffey said. – by Matt Hasson

As the primacy of LASIK is challenged as the refractive procedure of choice, what role does the lagging economy play in contrast to the increasing availability of alternative treatments?

Reference:

• Solomon KD, Fernández de Castro LE, Sandoval HP, et al; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009;116(4):691-701.

• Eric D. Donnenfeld, MD, can be reached at OCLI, 2000 North Village Ave., Rockville Centre, NY 11570; 516-766-2519; fax: 516-766-3714; e-mail: eddoph@aol.com.
• Richard J. Duffey, MD, can be reached at 2880 Dauphin St., Mobile, AL 36606; 334-470-8928; fax: 334-470-8924; e-mail: richardduffey@gmail.com.
• Daniel S. Durrie, MD, can be reached at Durrie Vision, 5520 College Blvd., Suite 201, Overland Park, KS 66211; 913-491-3330; fax: 913-491-9650; e-mail: ddurrie@durrievision.com.
• R. Doyle Stulting, MD, PhD, can be reached at Woolfson Eye Institute, 800 Mt. Vernon Highway, Suite 120, Atlanta, GA 30328; 770-255-3330; fax: 770-255-3331; e-mail: dstulting@woolfsoneye.com.
• Morris Waxler, PhD, can be reached at Waxler Regulatory Consultancy, LLC, 1920 Arlington Place, Madison, WI 53726-4002; 608-219-7547; e-mail: mwaxler@charter.net.
• Disclosures: Dr. Donnenfeld is a consultant for Abbott Medical Optics, Alcon and Bausch + Lomb. Dr. Duffey has no relevant financial disclosures. Dr. Durrie is a clinical investigator for Alcon and Abbott Medical Optics. Dr. Stulting is a consultant for Abbott Medical Optics and Alcon. Dr. Waxler has no relevant financial disclosures.