December 06, 2004

Eye Surgery Deemed Too Risky for NHS

Watchdog says the chances of damage in treatment do not justify widespread use

MOVES to make laser eye surgery available on the NHS are likely to be blocked by the Government’s clinical watchdog amid growing concerns over its long-term safety for patients.

A year-long review by the National Institute for Clinical Excellence (NICE) into the procedure known as Lasik, which is currently available only at private clinics, has concluded that current evidence on the treatment’s safety does not justify its widespread use on the NHS.

The decision comes after revelations in The Times of two American lawsuits alleging that a type of laser used by Boots, the high street chemist, could develop faults leading to blurred vision and damage to eyesight.

Boots, which was unaware of the concerns before being contacted by The Times, later announced that it would close its nine laser treatment centres by the end of the year after failing to win public confidence in the high-tech procedure.

Bruce Campbell, chairman of NICE’s interventional procedures advisory committee, said that there was very little information about how many people had been harmed as a result of the Lasik procedure.

A draft of the 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).”

Professor Campbell said that questions about the potential damage caused to some patients had not been answered, leaving the treatment a cause for concern.

“Lasik offers improvement to people who have mild or moderate trouble with their vision. 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,” he said.

“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 and 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.”

In its draft report, NICE concludes: “current evidence does not appear adequate to support its use without special arrangements for consent and for audit and research.”

As myopia can be corrected safely with spectacles or contact lenses NICE says that an alternative treatment “must have excellent safety to be suitable for use”.

Laser surgery, which was introduced in Britain in 1989 in the form of PRK (photo refractive keratectomy) costs about £2,000 to £3,000 and is performed on about 100,000 people each year in Britain.

The model Cindy Crawford, the actress Nicole Kidman and the singer Barry Manilow are among celebrities reported to have undergone the procedure.

Lasik is the most popular type, where a flap about one third of the thickness of the cornea is cut, the bed underneath reshaped using the laser and then the flap is replaced. Last year the medical journal Ophthalmology said that the failure rate for eye surgery was one in ten, not the one in a thousand figure widely advertised.

Which?, formerly known as the Consumers’ Association, has said 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. The Medical Defence Union said that negligence claims involving laser eye surgery had more than doubled among its members since 1998.

Minor side-effects that have been reported are dry eyes and night-time “starbursts”. It is estimated that in about 2 to 4 per cent of patients there will be a measurable decline in the quality of vision.

www.timesonline.co.uk/article/0,,2-1390686,00.html

Posted by Admin at December 6, 2004 12:03 PM