Blind World

Safety fears stop laser eye operations.

December 05, 2004.
The Times Online.

(United Kingdom) THE government's clinical watchdog is blocking laser eye surgery on the National Health Service because of concerns over its long-term safety for patients.

A year-long review by the National Institute for Clinical Excellence (Nice) has concluded that "current evidence" on the treatment's safety does not justify its widespread use in the NHS.

The decision will add to the controversy over the surgery, which has grown on the back of celebrity endorsement by stars such as Nicole Kidman.

Lured by the promise of "freedom" from wearing glasses and contact lenses, at least 100,000 people a year in Britain are now paying between 2,000 and 3,000 for "cosmetic" eye surgery to correct myopia.

Chains such as Boots, which sold its eye surgery business to Optical Express, used to claim "there are no known long-term side effects or complications" from the popular Lasik treatment. Another company, Ultralase, boasts a 98% success rate.

However, a draft of a Nice report, to be published on December 15, has concluded: "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)."

While the report concedes there is evidence laser surgery can help people with mild or moderate myopia, there is no clear evidence backing the safety claims made by many companies.

Nice points out myopia can be corrected safely with spectacles or contact lens. Therefore, "an alternative treatment must have excellent safety to be suitable for use".

The Medical Defence Union, Britain's largest insurer for doctors, has reported a doubling in the number of claims against clinics offering laser eye surgery since 1998. There is also evidence that many clinics have made overblown claims leading to exaggerated expectations and disappointment.

Last year the American Journal of Ophthalmology said the failure rate for eye surgery was one in 10, not the one in 1,000 figure widely advertised.

Which?, formerly known as the Consumers' Association, has warned that people having surgery are "gambling with their sight". It found that some clinics do not highlight possible side effects until after patients are signed up for treatment.

Boots was censured last year by the Advertising Standards Authority (ASA) for giving the impression that anyone having Lasik treatment would no longer require glasses or contact lenses and that complications with the operation had only arisen in America.

One potential complication, corneal ectasia, can lead to patients having to undergo a corneal transplant. According to Nice, The Royal College of Ophthalmologists and the US Food and Drug Administration have identified more than 20 other possible complications.

The surgery uses a laser to cut a piece out of the cornea, the transparent protective covering over the eye's lens. This procedure can correct a mis-shapen lens, which would otherwise require glasses or contact lenses. The operation, which is irreversible, takes 30 minutes.

Among those concerned about its safety is Rebecca Petris, who set up the patient pressure group Lasermyeye when she suffered complications after Lasik surgery. She came out of surgery with severe double vision and no night vision. She can no longer drive.

Petris said she hoped the report would alert the public to the difference between the claims made by clinics and the concerns of the medical profession. She stressed her organisation was not against the surgery but wanted to see higher standards.

Professor Bruce Campbell, chairman of Nice's interventional procedures advisory committee, said: "This is a problem that can easily be corrected by spectacles or contact lenses, so any risk of damage to the eye by Lasik is a real concern.

"Although many people have had Lasik treatment there is very little information about how many are harmed as a result.

"We know that vision gets worse in a few people after Lasik. Eye specialists are also concerned about the effects of thinning the cornea of the eye in the long term. We need to know more about these potential problems."

A spokesman for Ultralase, one of the first companies in the UK to offer laser eye surgery, said: "We believe this treatment is extremely safe."

The company disputes many of Nice's figures and claims that since 1991 there have not been any longer-term side effects from the surgery among its patients.

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