When Sohaib Ashraf underwent laser eye surgery to correct his short-sightedness, he was in and out of the clinic in 30 minutes — the procedure itself took just ten — but he had high hopes for the results.
‘I was looking forward to being able to see the numbers on the alarm clock in the morning and not having to fumble around for glasses any more,’ says Sohaib.
He had worn glasses since the age of five, and adds: ‘Like lots of people, I was fed up with them. I also wanted to improve my image, I was young and single at the time.’
The laser eye surgery was, indeed, life-changing — just not in the way he had expected. Since having the procedure six years ago, Sohaib, 32, who lives near Preston, Lancashire, with his wife Fahtima, 26, has developed blurred vision in his right eye, and ‘halos’ and glare in both.
Popular: Tens of thousands of people undergo laser eye surgery in the UK, each year
Even worse, he suffers from permanent, stabbing pain in his eyes.
‘It never stops — I haven’t had a decent night’s sleep ever since the surgery, as I need to wake up every hour to put in drops,’ he says. He also has ‘terrible’ depression and his weight has shot up from 13 st to 21 st — he’s 5 ft 11 in.
‘This so-called simple procedure has robbed me of the best years of my life in a split second, and there’s no cure,’ he says.
Sohaib had been treated with LASEK, where the cornea (the clear front part of the eye) is reshaped to correct vision faults.
He says: ‘It is so widely available, I thought it would be OK, especially as it was performed by highly qualified surgeons. I came across some horror stories on the internet, but I ignored them. I did some research on the best surgeons and found one in Manchester.’
Sohaib says he asked about the risks, but the surgeon ‘downplayed them as just dry eye, which he reassured me would go after six months’.
‘He told me complications were more common with older procedures and that patient selection had improved, reducing the risks. I even asked him if he’d let his kids have it done, and he said yes.’
Reassured, Sohaib underwent the procedure in January 2013. A week later, he started to feel sharp pain — ‘like I was being repeatedly stabbed in the eyes’.
‘I now know the pain was caused by recurrent corneal erosion syndrome — where the surface of the eye is destroyed by the eyelid, causing friction,’ he says. ‘Laser surgery can cause this because it removes the Bowman’s layer just under the cornea. This means the corneal cells are not anchored down and “erosions” can develop, where the cells are stripped away, exposing the corneal nerves, which are the most powerful pain generators in the entire body.’
Regrets: Sohaib Ashraf, from Preston, has been left with a constant stabbing pain in his eye
At the time, however, Sohaib was told it was dry eyes and he was given drops. But the problem didn’t improve and Sohaib found himself back at the clinic, month after month.
Eventually, he was diagnosed with recurrent corneal erosion and, two years after the original procedure, he was offered another, where a needle is inserted in the eye to create a pattern of scar tissue, to make the corneal cells stick down.
Sohaib turned it down because there was no long-term safety data. ‘I couldn’t risk my eyes getting any worse,’ he says. ‘What happened wasn’t a case of the surgeon making a mistake or using the wrong laser — I would argue that reshaping the cornea is a technique that is inherently dangerous.
‘What I also noticed was whatever surgeon I saw, they all wore glasses; do they know something we don’t about the risks?’
Bitter words, but not ones that can be ignored. For Sohaib is a trained pharmacist and a health economist at NICE, the National Institute for Health and Care Excellence, where his work involves scrutinising effectiveness, safety and economic data for treatments in clinical guidelines.
He has used these skills in his own research into laser eye surgery — and says what he has found is deeply worrying. Every year, around 100,000 Britons undergo refractive eye surgery, as it’s known, at a cost of around £4,000 for both eyes.
It is big business. The UK market alone is estimated to be worth at least £400 million a year. There are a number of techniques, including LASIK, where a flap is cut in the cornea and a deeper layer of the eyeball shaped, and LASEK, the type Sohaib had, which reshapes the eye’s surface.
With ReLEx SMILE, a newer technique, a deeper layer of the eyeball is reshaped via a tiny incision, rather than a flap.
The vast majority of patients are happy with the results, with surveys finding 98 per cent satisfaction rates with LASIK, for instance. The complication rate is regarded as ‘low’: the website of one leading ophthalmic surgeon puts it at ‘less than one in 1,000’ — typically dry eyes — and ‘in many cases’ the problem is ‘temporary’.
Afflicted: 'I haven’t had a decent night’s sleep ever since the surgery, as I need to wake up every hour to put in drops,’ he says
NICE itself, in guidance published in 2006, indicated the risk of a more serious complication, ectasia (where the cornea bulges, affecting vision), after LASIK was just 0.2 per cent.
And if things do go wrong, ‘then they can be fixed — we have good solutions,’ says Bruce Allan, a consultant ophthalmic surgeon at Moorfields Eye Hospital in London and a spokesman for the Royal College of Ophthalmologists.
‘In around 1 in 5,000 cases we will need to replace the cornea with a corneal transplant — but you don’t go blind with LASIK,’ he explains.
‘One patient in ten to 20 will need some minor fine-tuning procedure that will take around 15 minutes and a day to recover.
‘The Royal College of Ophthalmologists has published professional standards for refractive surgery, and it’s very safe in the UK now as these are enforced by the regulator.’ And yet, there are those stories of how it’s gone wrong.
In 2014, Stephanie Holloway, from Lee-on-Solent, Hampshire, was awarded more than £500,000 in damages after a judge ruled Optical Express had failed to warn her about the risks of LASEK.
She was reported to have been left with hazy vision and light sensitivity and had to live by candlelight.
There are lots of other cases, claims Sohaib, ‘but people can’t talk, as if they get a payout they have to sign a gagging clause’.
Just before Christmas, Jessica Starr, a well-known TV presenter in the U.S. and mother of two, took her own life days after saying publicly that she was still struggling with sight problems and eye pain following laser eye surgery in October.
The media has been previously criticised for ‘unfairly’ highlighting ‘rare’ cases when things go wrong, with one consultant we spoke to dismissing them as the stories of ‘frustrated litigants’. But sweeping patients’ experiences under the carpet won’t make the problem go away, says Sohaib.
Driven by his own experience, he retrained as a health economist in 2014 and has since identified worrying gaps in the safety data.
Risk: In 2014, Stephanie Holloway, from Lee-on-Solent, Hampshire, was awarded £500,000 in damages after a judge ruled Optical Express had failed to warn her about the risks of LASEK
He cites as an example a major review, published in 2016 in the Journal of Cataract & Refractive Surgery, of 97 research papers which concluded that overall, the outcomes of modern LASIK were ‘significantly better than when the technology was first introduced’.
Just 0.6 per cent of patients suffered sight loss of two or more lines on a sight chart, with only 0.8 per cent reporting dry eye after a year, the authors found, adding: ‘It is realistic to expect that with continued technological advancements, LASIK surgical outcomes and safety will continue to improve.’
Yet the majority of the patients were followed up for only a month, says Sohaib. And, he adds: ‘The source of up to 52 per cent of the data used is a mystery.’
One large study the researchers did identify, he says, was ‘a non-peer-reviewed article of LASIK outcomes after a month in people with low-to-moderate myopia at Optical Express, a large LASIK provider’.
‘That study was published in an Optical Express-sponsored supplement to the Journal of Refractive Surgery.’
He adds: ‘We’re repeatedly told any side-effects are temporary, but we have plenty of evidence to show they are not. I’ve also found evidence of a host of complications you won’t find mentioned on consent forms — including a risk of cataracts 15 years earlier than the rest of the population, a ten-fold increased risk of retinal detachment, and corneal neuropathic pain, which has driven some to suicide.
‘I find it unbelievable there isn’t more long-term safety data available for a procedure that has been around for 25 years, nor more high-quality data generally.’
One of the few long-term studies, published in the Journal of Cataract & Refractive Surgery in 2016, followed up 2,530 LASIK patients over five years.
It found 91 per cent of patients were satisfied with their treatment, with fewer than 2 per cent reporting visual disturbances. The study’s lead author was a global director for Optical Express, and satisfaction rates are not a substitute for safety data, argues Sohaib.
Dr Morris Waxler also believes the risks and rate of complications have been downplayed. As a former head of department in ophthalmology at the U.S. Food and Drug Administration (FDA), Dr Waxler chaired the original panel that approved LASIK surgery in the Nineties.
Dangers: Ian Waghorne from Marple, Stockport, who is a software engineer who had lasik eye surgery in November 2017 and has suffered
