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U.K. agency issues guidance on LASIK surgery amid media furor
The clinical advisory body recommended thorough patient consent and longer follow-up studies after LASIK procedures in the NHS.
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An advisory group to U.K. government regulators issued a guidance on laser eye surgery in December. The group's report was preceded by premature, sensational newspaper reports that caused deep concerns among ophthalmologists in the United Kingdom and elsewhere.
The report from the U.K. National Institute for Clinical Excellence (NICE) voiced concerns about the long-term safety of LASIK surgery. It recommended that, if the procedure is to be performed in the U.K. National Health Service (NHS), practitioners should raise patients' awareness of potential risks and should audit and review long-term clinical outcomes.
"We know that vision gets worse in a few people after LASIK, and eye specialists are also concerned about possible long term side effects. We need to know more about these potential problems," said Prof. Bruce Campbell, chairman of the Interventional Procedures Advisory Committee of NICE, in a statement.
The guidance is based on a year-long literature review of studies of the safety and efficacy of LASIK, as well as expert opinions. Eight studies were analyzed, including one systematic review of previous reports. The NICE emphasized that the guidance applies only to LASIK being used to treat refractive errors.
According to the NICE guidance, the studies reviewed showed that the effects of LASIK on vision were more predictable in eyes with mild to moderate myopia than in those with moderate to high myopia. In addition, the length of follow-up was not great enough to make assessments about long-term efficacy, the document said.
The experts consulted in the guidance said that the primary problem with LASIK surgery is the long-term risk of corneal ectasia. The experts consulted were not named in the report.
Problems with the guidance
In a statement in response to the NICE report, a group of ophthalmologists noted that the report does not condemn LASIK out of hand: "It has been made clear by NICE that well-conceived procedures performed within the NHS that are well-performed and well-audited should continue," the statement said.
These ophthalmologists, including members of the United Kingdom and Ireland Society for Cataract and Refractive Surgeons (UKISCRS), pointed out two major problems with the document that they claim will attract severe criticism and negate the benefits NICE had hoped to achieve. First, they said, the guidance fails to take into account recent studies and recent developments in laser refractive surgery such as wavefront-guided LASIK.
"There is little reference to the more recent large studies with good outcomes," said UKISCRS President Paul Rosen, FRCOphth, and four colleagues in a written statement.
The most recent study cited by NICE was from 2002, the statement said, while in April 2003 data was presented at the American Society of Cataract and Refractive Surgery illustrating the benefits of wavefront-guided LASIK. A second problem they cite is the NICE report's emphasis on corneal ectasia, which they point out is an unusual and easily predicted complication.
"These errors [in the NICE report] are likely to cause significant distress for patients and increase spurious litigation claims," the statement said.
"We have already seen misinterpretation by the press, and there is consternation from European colleagues and societies who up until now have held NICE in high regard," the surgeons said, referring to the premature newspaper reports.
Initial reports cause alarm
A news article describing the then-unreleased NICE report appeared in the London Sunday Times on December 6. It startled ophthalmologists with the headline "Eye surgery deemed too risky for NHS." This was followed by additional speculative coverage in the lay press.
The initial press reports were based on a draft guidance that preceded the official final guidance. The line from the NICE report that drew attention in the news reports read: "There are concerns about the procedure's safety in the long term, and current evidence does not appear adequate to support its use without special arrangement for consent (from the NHS)."
The NICE report came as a shock to surgeons who had been using laser refractive surgery procedures for 15 years, said Julian Stevens, FRCOphth, Associate Medical Editor of Ocular Surgery News Europe/Asia-Pacific Edition.
"The reason the press is all stirred up, and the reason many refractive surgeons in the private sector are all stirred up are, of course, because obviously there is a big financial issue because it's a very negative story," Mr. Stevens told OSN in a telephone interview shortly after the report's release.
"Much of the media speculation surrounding NHS refractive surgery and the NICE report is factually totally incorrect," Mr. Stevens said.
Therapeutic vs. cosmetic LASIK
According to Kathy Evans, chief executive of the Royal College of Ophthalmologists, most LASIK treatment in the United Kingdom is performed in the private health sector, not the NHS.
But the NICE report may affect the future of laser refractive surgery in the NHS, Mr. Stevens said. Many NHS patients have benefited from it since it was first performed at Moorfields Eye Hospital in 1990, he said.
"The current level of NHS activity in this area accounts for approximately 0.8% of U.K. treatments (800 treatments carried by NHS in 2004)," Mr. Stevens said in a written statement circulated to many ophthalmologists in the United Kingdom.
In this statement, written in response to the initial media reports, Mr. Stevens reminded ophthalmologists of the official definition of eligibility for NHS surgery: "Refractive surgery is available as an NHS procedure where surgical vision correction is likely to provide vision correction or ocular comfort and this is not achievable by spectacle or contact lens or where spectacle or contact lens corrected vision is of insufficient quality for occupation or driving."
Mr. Stevens said ophthalmologists fear that patients who need refractive surgery will now be apprehensive about getting the proper care.
"The idea is that if you can wear a spectacle or contact lens, then free public health laser refractive surgery is inappropriate. But if you had a road traffic accident, if you lost the lens in your eye, or you had cataract surgery and those wounds had high astigmatism, then it's entirely reasonable to consider refractive surgery to achieve and regain vision and ocular balance," Mr. Stevens said.
Implications of the report
Although the NICE report is aimed at only LASIK performed in the NHS, Mr. Stevens said media coverage may cause a ripple effect of apprehension of laser surgery to spread throughout the British health care system and beyond.
"If felt to be unsatisfactory for the NHS on the basis of safety, then the same would apply in the private sector, and there would have to be a good rationale for continuing treatment in spite of NICE guidance," Mr. Stevens said.
According to Mr. Stevens, performing LASIK is going to become more risky for U.K. surgeons as they will have to face patients and their legal representatives wondering why their doctors performed a procedure that entails excess risk. "My guess is that learned people in courts of law internationally will quote [the NICE report] on both sides of the Atlantic," Mr. Stevens said.
For Your Information:
- Julian Stevens, FRCOphth, can be reached at Moorfields Eye Hospital, London EC1V 2PD, England; 44-207-251-4835; fax: 44-207-431-8622; e-mail: JulianStevens@compuserve.com
- The National Institute for Clinical Excellence can be reached at MidCity Place, 71 High Holborn, London WC1V 6NA, England; 44-20-7067-5800; fax: 44-20-7067-5801; e-mail: nice@nice.nhs.uk
- The Royal College of Ophthalmologists can be reached at 17 Cornwall Terrace, London NW1 4QW, England; 44-20-7935-0702; fax: 44-20-7935-9838.
- Jared Schultz is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses geographically on Europe and the Asia-Pacific region.