The new dangers of laser eye surgery

Walk in, walk out, and see! Such is the positive spin on laser eye surgery – the supposed ‘band-aid’ procedure for short- and long-sightedness – that in the public mind “it’s like having a filling at the dentist”, says leading laser surgery expert David Gartry, a consultant ophthalmic surgeon at Moorfields Eye Hospital in East London.

In the States, it’s even been advertised as a ‘beauty service’ for June brides-to-be, so they can avoid the camera flash on glasses or losing a contact lens while enjoying diving lessons on their Caribbean honeymoon.

Thanks to hard-sell tactics by high-street shops that offer a walk-in service, every year some hundred thousand British people now submit to the procedure in the hopes of forever ridding themselves of glasses and contacts, three-quarters of them making use of one of the high-street big three: Optical Express, Optimax and Ultralase. Across the Atlantic, three-quarters of a million Americans submit to the laser every year, mostly at walk-in centres like TLC Laser Eye Centers.

What doctors and high-street eye specialists tell you

• It can be done over a lunch hour: each eye takes just 20 minutes
• It can be handled successfully at very little cost – less than £500 per eye
• It’s simple surgery and complications are extremely rare
• All doctors and specialists are specially trained
• There’s a cooling-off period between the time you are informed about the procedure and the actual operation
• The procedure will be explained by a ‘refractive surgeon’, the specialist who will actually do the operation.
• According to the sales hype, 99 per cent of patients have successful results. On its website, Optimax claims that 99.83 per cent of some 4,000 customers with very mild myopia achieved ‘driving-standard’ vision, and 95.99 per cent achieved 20/20 vision during a two-year period between 2007 and 2009. Optical Express claims a 99 per cent success rate with the more than 300,000 patients with the “most common prescription ranges” it serviced.

What doctors don’t tell you

But these cherry-picked statistics gloss over what has happened to their full patient population, including those who don’t have mild myopia or, indeed, when the procedure goes wrong – as it has

for millions of people in the US and UK. Although the US Food and Drug Administration (FDA) tracks complaints through its MedWatch programme, many LASIK facilities don’t report complications and are not required to do so. In fact, most patients are not even told they can file such a report, which is why the side-effects of the procedure are so grossly underreported in America. Consequently, it is left to organizations like Lasik Complications (www.lasikcomplications.com) to collect case histories and offer alternatives.

In the UK, the situation is similar. There is no requirement to report side-effects – in fact, no requirements other than a medical licence for anyone handling the procedure, full stop. Sasha Rodoy, a 57-year-old Londoner and former fashion designer whose eyes were ruined by laser surgery in 2011 (see box, page 61), is now campaigning for stiffer regulations. In just a few years, she’s been contacted by at least 3,000 people who say they’ve suffered debilitating complications.

It was only in 2008 that the FDA added an online link for adverse reports on its LASIK website, at which point the complaints started flooding in.

Advocates claim that new developments and equipment have made the procedure safer,
but the latest studies and surveys paint a very different picture.

• Patient reports of significant side-effects are steadily mounting. In all of 2014, the FDA received 1,801 claims of adverse events; in the first five months of 2015 alone, the agency received 499 reports. And it’s likely these figures are highly conservative.
• The latest research shows alarming numbers of problems. In the FDA’s own long-awaited report, the LASIK Quality of Life Collaboration Project, up to 45 per cent of people who had no problems before LASIK now complain of visual symptoms like ‘halos’ and ‘starbursts’ or ‘glare’, making it more difficult to see, and 30 per cent of people suffer from dry eyes. What’s more, 4 per cent of patients reported ‘very’ or ‘extremely’ bothersome symptoms, and 1 per cent had extreme difficulty or found it impossible to do normal activities because of their eyesight.1
• Technology isn’t improving the batting average. A review of 12 clinical trials, including the latest wavefront technology, which takes account of the eye’s surface shape and any tiny aberrations, shows that just six months after having LASIK, 17.5 per cent of patients report halos, 19.7 suffer from glare (starbursts), 19.3 have night-driving problems and 21 complain of eye dryness.2
• Doctors who themselves have undergone LASIK are dissatisfied. In one study, 50 per cent of doctors who’d had LASIK were left with irritated eyes, 35 per cent had trouble seeing in dim light, 43 per cent had glare and 41 per cent complained of halos.3

The Royal College of Ophthalmologists has issued guidelines for the kinds of skills and experience necessary to handle this sort of procedure, and recommends that surgeons handling laser eye surgery carry out at least 500 procedures a year – and even offers a training scheme.

But the training is strictly voluntary, and the guidelines have been virtually castrated by legal threats from this multimillion-pound industry. Rodoy is essentially a one-woman lobbyist in the UK, as the government continues to drag its feet.

And the problem may not be just down to inexperience. FDA whistleblower Morris Waxler, who was the head of the FDA’s ophthalmological devices unit in 1998, when the FDA approved the first devices to perform LASIK, claims that the procedure’s surgeons and device manufacturers exaggerated its safety, and hid evidence from him and other members of the FDA about its side-effects in poorly designed clinical trials.

He is joined by two other FDA whistleblowers, who claim that the FDA has buckled under industry pressure, downgrading serious adverse effects like potentially crippling impaired night vision, extreme dry eye and blurred vision to mere ‘complications’ to avoid being included in the 1 per cent tally the FDA has set as the upper limit for acceptable adverse events.

This means patients with severely weakened corneas – which could render them legally blind – are often told they have ‘keratoconus’, which has similar symptoms but is a disorder that
happens naturally.

Such is the spin on laser eye surgery that, of all the surgical procedures out there, patients are the least likely to do any research into the procedure except to find the cheapest deal, according to a 2012 study by the UK’s Competition Commission, which discovered this while investigating a takeover of one high-street brand by another.

Most patients consent to the procedure with no knowledge of how it works, how experienced the operating surgeon is and whether it entails any risks.

In fact, many are pressured into having the surgery on the same day they have their consultation, after having only seen an assistant, rather than a doctor, and certainly not the surgeon who will eventually be working on them. A document from Optical Express specifically discusses how “front-of-shop” personnel should “take control” of customers, urging them to get the procedure done then and there.4

Here’s what you should take on board before a laser is aimed anywhere near
your eyeballs.

What the high street won’t tell you

• Complications are not rare. The Royal College estimates that complications affect up to 5 per cent, or one in 20 people – and that’s a conservative guess. According to injured US patient Paula Cofer, at least se
  ven Americans have committed suicide because of LASIK surgery gone horribly wrong, while two others have attempted suicide and countless other patients have suicidal thoughts.
• You may be left with a steadily weakening cornea. In up to 40 per cent of cases, the LASIK technique has caused the cornea to weaken.5 In some instances, this weakened cornea will revert to its original shape – leaving you short-sighted again.6 Your myopia could also become progressively worse. In severe cases, the cornea buckles, causing post-LASIK ectasia (corneal bulging), with such distorted vision that patients are considered legally blind.
• Your eyes can get infected, causing keratitis, or inflammation of the cornea, up to a year and a half after surgery, which can be serious enough to threaten your eyesight.7
• You may experience a delay in recovering your visual sharpness and continue to experience ‘corneal haze’.8
• You may suffer from dry eye, which can affect your tear function permanently.9 Dr Anat Galor, a surgeon at Bascom Palmer Eye Institute in Florida, says an estimated 20 to 30 per cent of LASIK patients have painful and itchy dry eye, which is manageable, but 5 per cent will have severe dry eye, a permanent state of severe discomfort requiring the constant use of eye drops or moisture goggles. Nearly 1 per cent of patients, Galor estimates, are completely unable to function as a result.
• You could suffer a detached retina, ‘cross-eyes’ (strabismus) and macular damage.10
• You could end up with optic-nerve damage, permanently affecting
• your vision.11
• Surgical complications can turn a simple case of myopia into irregular astigmatism(a misshapen cornea), leaving you with blurred or distorted vision.12
• You could completely lose your vision due to complications. In a study of 24 complications of all varieties, 13 happened during the procedure. The technique itself, the researchers concluded, may result in serious complications leading to visual loss, as it did with singer Mel B (see end of article).13
• You can develop impaired night vision and loss of contrast sensitivity, making it hard to distinguish objects placed against a similarly coloured background.14
• You are still likely to need to wear glasses for some tasks, says David Gartry, and your eyes will continue to change as you age.

The bottom line: You can’t go back and fix a botched job, as you can with other surgery. “Lasers can certainly remove corneal tissue, but no technology can replace it,” says the Lasik Complications website.

Your only recourse is to consult the likes of Miami optometrist Dr Edward Boshnick, OD, who specializes in treating patients who have complications due to refractive eye surgery, and can fit specially made contact lenses like scleral lenses.

Blinded by the light

The dangers of laser surgery emerged after Mel B, formerly of the Spice Girls, admitted that she is blind in one eye after undergoing laser surgery. “I can’t see at all out of my left eye, the operation went so wrong,” she said. Her only alternative is to wait for a corneal transplant, where a portion of her eye will be replaced by tissue from a recently deceased donor.

Sasha Rodoy, a 57-year-old Londoner and former fashion designer had average myopia and only wore glasses for distance when she decided to get the surgery in 2011. Now she needs glasses full-time – three prescriptions, for distance, intermediate and close up vision. Plus she suffers a long list of debilitating side-effects, including dry eyes, photophobia, starbursts from lights at night, and loss of depth perception.

One woman on the Lasik Complications website who underwent surgery in 2006 reports that, about a year later, she suffered buckled corneas in both eyes. In 2008, in an effort to correct her distorted corneas, she underwent another surgical procedure known as CK (conductive keratoplasty). In 2014, the right corneal flap became dislodged and her cornea perforated, and she underwent an emergency corneal transplant, making it necessary to use steroid drops to avoid transplant rejection. This, in turn, caused a large spike in the intraocular pressure of her right eye, risking glaucoma.

To bring down the pressure, a shunt was surgically placed in her eye, causing irreversible damage to her optic nerve. She is now blind in her right eye. The Lasik Complications site calls this
“the domino effect of unnecessary refractive surgery”.

LASIK or LASEK?

Laser eye surgery works by directing a laser beam directly onto the bed of the cornea (the transparent tissue covering the front of the eye) to shave and reshape it – flattening out the tissue in people who are short-sighted and making it more pointed in eyes with long-sightedness.

LASIK (laser in situ keratomileusis), the most common technique, makes use of a special knife to lift a flap of tissue from the surface of the cornea to get at the corneal bed; this flap is replaced right after the laser has done its job.

With the LASEK (laser subepithelial keratomileusis) procedure, now usually only carried out when the cornea is deemed to be too thin for LASIK, alcohol is applied to soften the outermost cell layer (epithelium) of the cornea, so it can be moved to one side. After the laser has reshaped the corneal surface, the cell layer is shifted back into place.

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