According to a recent article in the Daily Mail, laser eye surgery chain Ultralase “is in talks with its bankers to refinance its debt just two years after a pre-pack administration saw the lending banks take over and owner 3i lose its entire £174million investment.”

Ultralase directors admit in the article that “…if business declines or the negotiations break down, there would be a ‘significant doubt’ that the company could continue.”

According to the Mail, “Recently filed financial documents show that Ultralase’s immediate parent company, CLVC Group, breached its banking covenants several times last year and also at the end of March this year.”

“Its backers, which include Royal Bank of Scotland and Barclays, have already agreed to defer some costs and interest payments and the company’s directors say they are ‘confident’ that the new financing will be agreed.

“Ultralase has been suffering from the slowdown in nonessential consumer spending.”

Read more: m.dailymail.co.uk/money/markets/article-2140284/Laser-eye-surgery-specialist-Ultralase-talks-banks-refinance-debt.html

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This article on corneal inlays by Dr Dan Durrie was featured in this month’s EyeWorld magazine. Dr Durrie describes the evolution of corneal inlays, culminating in the development of the most advanced version, the KAMRA inlay from AcuFocus.

Clarity for KAMRA

by Daniel S. Durrie, M.D.

The KAMRA corneal inlay Source: AcuFocus

The AcuFocus KAMRA inlay for the treatment of presbyopia Source: Perry S. Binder, M.D.
The KAMRA corneal inlay by AcuFocus (Irvine, Calif.) is gaining traction as a great option for treating presbyopia in markets that have access to it, such as Europe, the Middle East, and Asia-Pacific. The inlay works based on the principle of small aperture optics and provides improved depth of focus to improve near vision while having minimal impact on distance vision. The KAMRA inlay is the result of decades of study on corneal inlays. Jose Barraquer is accredited to be the first to experiment with corneal implants in 1949 (1).

A series of improvements took place, but early generations of inlays suffered from poor predictability, loss of acuity over time, haze, corneal thinning, and decent ration.(2-4) The development of new biocompatible materials and experimentation with optimal placement, however, have changed the history of corneal inlays and the treatment of presbyopia. I first started working with hydrogel inlays to correct aphakia in 1985. The porous nature of the hydrogel material made these well tolerated by the cornea, whereas inlays made out of polysulfone caused corneal thinning and melting due to their poor permeability. This was one of the first indications that in order for an inlay to be tolerated by the cornea, the biological principals of the cornea must be maintained. That includes an inlay of material that allows glucose to go through the cornea and nourish the corneal epithelium.

The KAMRA inlay has gone through six design iterations, starting with the original design that was made from Dacron fabric and was 25 microns thick. Over time, the platform has transitioned to polyvinylidene fluoride, a highly biocompatible material that is used routinely in IOL haptics. Further, the inlay has been reduced in size to just 5 microns thick in the current design. The number of microperforations has increased from 1,600 to 8,400, and these are arranged in a pseudorandom pattern to allow for appropriate nutrient flow and to minimize light scatter. Although melts occurred in a prior generation of inlay and with an earlier procedure, to date there have been no flap melts in the current clinical trial that will be submitted for approval next year.

In addition to the evolution in materials and design, numerous clinical studies over the past 7 years have led to the optimal depth placement in the cornea. Early studies demonstrated that shallow placement of the inlay has the potential to create some stress on the cornea, causing corneal shape change and thinning and ultimately resulting in an explant of the inlay. After performing a series of studies we also found that if the inlay was implanted too deeply, we had much lower visual recovery. The inlay should be implanted at an optimal depth of 200 microns. When kept at this depth, the cornea tolerates the inlay very well.

Development in other areas of ophthalmology has also aided in the advances in the corneal inlay procedure. The femtosecond laser allows surgeons to program what they want, and then it is executed with precision. This permits them to not only control the depth, but also the configuration of the incision. The precision of the laser allows us to make pockets at certain locations in the cornea, aiding with centration.

Another new technology now in use, the AcuTarget System, provides surgeons with real-time inlay placement guidance within 100 microns of the intended placement location, as well as objective placement assessment post-op. This surgical aid has the potential to reduce procedure time, resulting in quieter eyes in the immediate post-op period. In addition to historical data dating back to the 1960s, in-depth, international, multicenter clinical trials have provided evidence of the safety and efficacy of the KAMRA corneal inlay. With the transition from an investigational product for many years to a commercially available product outside of the U.S., there are now over 8,000 inlays implanted in Japan, Australia/New Zealand, Europe, the Middle East, and South America, without any corneal thinnings and with good patient satisfaction.

References

1. Barraquer JI. Queratoplatica Refractiva. Estudios e informaciones Oftalmologicas. 1949;2:10.
2. Deg JK, Binder PS. Histopathology and clinical behavior of polysulfone intracorneal implants in the baboon model. Polysulfone lens implants. Ophthalmology. 1988;95:506-515.
3. Alió JL, Mulet ME, Zapata LF, Vidal MT, De Rojas V, Javaloy J. Intracorneal inlay complicated by intrastromal epithelial opacification. Arch Ophthalmol. 2004;122:1441-1446.
4. Choyce P. The present status of intracameral and intracorneal implants. Can J Ophth.1968;3:295-311.

Editors’ note: Dr. Durrie has financial interests with AcuFocus.

Contact information

Durrie: 913-491-3330, ddurrie@durrievision.com

The KAMRA Inlay is a breakthrough in correcting the need for reading glasses, and is now our primary treatment for anyone aged 45 upwards. You can read an article from yesterday’s London Evening Standard all about KAMRA. It features Karen who had the Keyhole KAMRA version, where no LASIK-type flap is created, and the inlay is simply inserted into a tiny pocket through a keyhole entrance. Unlike LASIK, there is no significant dry eye and the patient could even rub their eyes afterwards without risk of dislodging anything.

You can see the full article here: www.thisislondon.co.uk/standard/article-24014966-london-clinic-develops-10-minute-operation-to-freeze-failing-eyesight.do

You can learn more about KAMRA and presbyopia here at KAMRAvision.com

A direct mail advertisement by Optimax Laser Eye Clinics, which said ‘we’re the UK’s number one Laser Eye Surgery specialists’ has been banned by the ASA, according to the drum.co.uk. A complaint had been made by Optical Express about the advert, which also claimed that Optimax had ‘the best corrective vision treatment in the country’.

Optimax said the ad was an oversight because they had been ensuring they were careful to avoid comparative and superlative claims in their advertising. Since the advertising Standards Authority did not receive any evidence to back the claims of being number one for laser eye surgery, or for having the best vision corrective treatment in the country, the regulatory body decided that the advert breached the CAP code on misleading advertising and substantiation. It said that the advert must not be shown again in that form.

Cataracts develop as part of the aging process, so everyone is at risk eventually. According to a recent article from the American Academy of Ophthalmology, the risk factors include:

Advanced age;
Diabetes;
A family history of cataracts;
Extensive exposure to sunlight;
Smoking;
Obesity;
High blood pressure;
Previous eye injury or inflammation (swelling) in the eye;
Previous eye surgery;
Long-term use of steroid medication (especially combined use of oral and inhaled steroids).

If you have any of these risk factors, and your vision is not as clear as it once was, then you may be developing cataracts. Visit your local optometrist as the first port of call for an eye health check and refraction.

Cataracts are readily treatable with a local anaesthetic operation. Multi-focal implants are also available to restore both distance and near vision, reducing or eliminating your dependence on all glasses.

According to a news report in Cataract and Refractive Surgery Today, vegetarians may have a reduced risk of developing cataracts, based on a study in the American Journal of Clinical Nutrition.

Researchers at the University of Oxford in England studied the lifestyle characteristics of 27,670 self-reported nondiabetic participants aged 40 years and more by using data from the Hospital Episode Statistics in England and Scottish Morbidity Records.

Participants were asked to fill out dietary surveys between 1993 and 1999; their medical records between 2008 and 2009 were monitored to see if they developed cataracts. Almost 1,500 participants had cataracts during the follow-up period. The data showed that vegetarians and vegans were 30% to 40% less likely to develop cataracts than individuals who consume high amounts of meat.

“There are many good reasons to follow a healthy diet, and our study suggests that lowering your risk of cataract can now be added to these,” lead author Paul Appleby, senior statistician, Cancer Epidemiology Unit at the University of Oxford, said in an e-mail to Cataract & Refractive Surgery Today. “How far individuals move along the path toward a plant-based diet is a matter of personal choice.”

There was a strong relationship between cataract risk and dietary group. A progressive decrease in the risk of cataract was shown in those who consumed high amounts of meat—100 g (? 3.5 oz) daily—to moderate meat eaters (1.7- 3.4 oz), low meat eaters (> 1.7 oz), fish eaters (participants who ate fish but not meat), vegetarians, and vegans, with risk ratios of 0.96, 0.85, 0.79, 0.70 and 0.60, respectively.

The authors point out that eating meat does not necessarily promote cataract formation, rather it is vegetables that may have protective nutrients that lower cataract risk. Additionally, vegetarians may practice other healthy behaviors that can contribute to a lower risk of developing cataracts.

“There was no obvious explanation of our findings in terms of specific nutrients. It may be that diet group is simply a better marker of a healthy diet than the intake of any given nutrient,” Mr. Appleby said.

I had this interesting question from Sophie:

Dear Mr. Allamby, My father has keratoconus, I believe he has had it a long time but was diagnosed officially at an eye test when he was 30 (he is now 50) will this affect my chances of laser eye surgery and would it be safe to proceed if I show no current symptoms (I am 21).

Many thanks, Sophie

Dear Sophie, Thanks for your question. Keratoconus (KC) is most often sporadic (not apparently inherited) but has been observed to run in some families. Typically it is first seen in adolescence. Around 80% of cases do not progress. As you are now 21, if you have KC there may well be changes in the corneas already so the best next step would be to see you for corneal scans. These are now very sophisticated at picking up even early changes of KC before they would affect your vision.

We perform thin-flap femtosecond LASIK with our new Crystal Line Ziemer down to 500 microns central corneal thickness (CCT). Below that we would normally do PRK, and also PRK if there is any slight irregularity in corneal shape. However, it is the appearance on the scans that is more important in your case, and CCT is only one of the risk factors we look at when considering suitability.

I am rather obsessed with safety, and any doubt whatsoever means I would advise against any treatment, even if you were very keen!

I had this interesting question recently from Kevin:

Hi Doctor, Would you please advise if “zlasik” is still better and newer technology compared to “ilasik with iFS Advanced Femtosecond Laser”?  Thanks

Hi Kevin, I prefer the Ziemer system (Z-LASIK). We have the brand new Ziemer LDV Crystal Line system, currently the only one in the UK, and it is a remarkable flap creation tool. It has a 33 times faster repetition rate than the latest iFS 150KHz model, with energy per pulse far lower, tighter energy focus and the shortest suction-on time. We can do both eyes safely and very accurately in around 6 minutes.

You may have seen this article on laser eye surgery in the Daily Mail last week. The article describes the serious complications suffered by Lois Roberts following her laser eye surgery 3 years ago.

Yet, instead of the simple pain-free experience Lois was led to expect, the surgery to correct her short-sightedness left her in agony for days. Worse, three years on, she still has painfully dry eyes as a result of damage to the nerves that stimulate tears. Lois has to apply eye drops daily – which in itself is a problem, as long-term use can raise the risk of chronic eye inflammation. Dry eyes can also lead to serious infections and, ultimately, even loss of vision.

As well as dry eyes, Lois suffers from constant floaters and poorer night vision. ‘The floaters are like clumps of black lines and dots,’ she says. ‘I’ve been reassured they’re harmless, but they are incredibly annoying.’

How accurate was this piece? Sadly, not very much at all. Interestingly, Lois herself added the following comments on the online version of the article:

Hi all – I’m Lois from the article I just wanted to confirm that I do NOT regret having laser eye surgery. I was shocked when I saw a huge picture of myself saying that laser eye surgery has ruined my sight! This is not true. For me personally, I don’t find the dry eyes and floaters a big problem, yes they’re annoying but hey it’s worth it for me. Also, I would never EVER have had laser surgery after watching an advert on the tv! I had it done in Manchester, the same place as my father had his done very successfully around 15 years ago. I thought this article was going to look at the positive and negative effects of laser surgery. For me, it’s great to be able to surf and play sports without having to worry about whether I’d be able to put my contacts in. Anyway, I feel better now I’ve had a little rant! Thank you for some of the lovely comments!

- Lois, North Wales, 01/12/2010 11:04

Another reader, Andy, added his feelings on this:

Thankful that Lois has been able to put in a comment that counters the sensationalism of this article … But you do get what you pay for! … There are enough alternative, highly rated clinics out there with fantastic reputations that you can choose from. Do not undervalue your eyes – laser eye surgery IS surgery and should not be treated like buying anything else on the high street. Please do your research into laser eye surgery clinics and you will avoid the problems detailed in this sensationalist article.

- Andy, Guildford, Surrey, 01/12/2010 17:30

You should look around carefully before choosing the clinic and surgeon for your laser eye surgery. You get one pair of eyes, after all. If you are unlucky enough to need to wear glasses, laser eye surgery is a realistic option and safe in the right hands. The latter emphasis is important. For example, dry eyes occur in those who had dry eye before the procedure, and these patients should not have LASIK.

Kate asked:

Hi,

I’ve been to consults at two clinics, one that does PRK, and the other LASIK (with a blade). Both clinics offered a similar quote and both said I was an ideal candidate for the surgery (I’m a healthy 23 year old female with mild astigmatism and the same prescription of -1.5 in both eyes since I’ve had glasses (2001). The only thing a out of the norm is that my corneas are a little steep (46). Is there going to be a benefit to me choosing one surgery over the other?

Cheers, Kate

Julie asked:

Dear Dave, I am about to get an enhancement surgery since my eye changed to -1.0 after just 10 months. I got the flap cut with the laser. I see that this type of cut heels quickly and I know doctor will not be using the cutting laser again, so how is he going to lift the flap? I’m terrified and thinking that I will be better off wearing glasses again. What do you think?  Thank you

Hi Julie
We lift flaps manually, using a special instrument designed for lifting, which is usually a fairly simple process. It should be possible to lift a femtosecond flap at 10 months, but you wont know until it is tried. I had one patient that proved impossible to lift after 6 months, but that was unusual. You could opt for PRK enhancement with mitomycin, but I would opt normally to lift the flap first. You can discuss this with your surgeon before going ahead.
We are now hitting 100% for patients seeing 20/20 or better at my clinic, Focus, so enhancements are getting increasingly rare. If they do happen, it is usually for patients with very high myopia.
Best regards, Dave

Winston asked:

I am 19 , with -6.25 in the left eye and -7.25 in right. I have been wearing glasses for about 9 to 10 ten years.
What would you recommend? I do boxing as well as other physical activity.

Meera asked

Trudi asked

Hello Dave,
I had my eyes lasered in Dec 2009. My prescription was SPH -4.50 & -5.00. My left eye (which had the worst prescription) is perfect! I have had enhancement surgery on my right though as a slight astigmatism remained. I had enhancement surgery (using the LASEK method this time round) 4 wks ago and the vision is not yet as good as it was after the first surgery, before the enhancement. I am beginning to think I should have lived with the result I had after the first surgery and been grateful. Do you think my eye will heal to at least what it was after the first surgery?

Also, I have regular post-op check-ups with various different opticians (dependant on who’s in on the day of my app) and each tells a different story about healing and drops. I have been told that keeping the eyes wet with blink drops is *very important* to aid healing. I have also been told by another optician that I only need to put drops in when my eye feels dry. What is your view?
Thanks.

Trudi, for the lubrication, I would recommend regular instillation rather than just when they feel dry. The nerves are lasered during the treatment and see the eye is somewhat insensitive for a while, so you may not be aware of some dryness and so not lubricate. Aim for 4-6 times a day over the next couple of months. I prefer the preservative free version (you can buy e.g. Blink or Refresh over the counter at Boots) which will be less irritant with regular usage over an extended period. These are the ones in individual droppers. One vial should last you a day, one drop in each eye every 3-4 hours.

For surface laser correction (PRK/LASEK) the full result can take months to fully settle and the vision is often a bit off at 4 weeks post-op. You should find it will settle more over the next 4-8 weeks.

Graeme just asked:

Hi Dave,

Two weeks ago I was treated with wavefront guided LASIK with Intralase by [clinic name deleted].

Although my vision was very good from the following day, I have had problems at night with severe starbursts, glare and halos around fluorescent lights (even indoors). I was told a couple of days ago that it will get better with time but since it’s hardly got better since day 1, I think there is a slim to no chance of this happening, especially as the eyes otherwise feel good with excellent vision.

Also, I was told a number of times that I had very large pupils which is why I needed wavefront guided LASIK to prevent my night visiion being affected. In hindsight and reading further on the Internet (which I now realise I should have done much more of) .

I guess I’m asking is there anything that I can do about this, anything I should ask them, e.g. pupil dilation, treatment area or anything like that to determine the reason for the starbursts and the fact that it hasn’t been done 100% correctly or I shouldn’t have been recommended as suitable? Or is there anything that can be done to improve it?

I wouldn’t obviously want further surgery but I’ve seen on this page info about more modern lasers and larger treatment areas that you have used which almost eliminate night vision problems. Could this be an option? Although I have paid out £3000 so far and so wouldn’t welcome another big outlay especially without guarantees of success. My main problem is that come the winter I won’t even be able to get to work if my night vision remains as bad as this.

I would be grateful for any suggestions or advice that you have.

Graeme, it is still very early after your treatment, so I think the advice from your clinic to wait is correct. I would normally allow 2-3 months for the vision to settle fully before looking if anything else needs doing, especially if it was a particularly large prescription. So please be patient for now.

Keep in contact with your clinic, and repeat testing at 4, 8 and 12 weeks post-op can help monitor your progress and relieve anxiety. You would want refractions and wavefront scans in particular, as night problems can arise from both low and high order aberrations. Low order means your prescription, but from your description your distance vision is excellent so not likely to be much prescription left – but you can confirm at your next visit.

It can occur if the treatment zone was significantly smaller than the scotopic (dark conditions) pupil size but clinics and doctors are well aware of this and modern lasers can treat a wide area of the cornea. You can ask about your dark pupil size and the full optical zone used at your treatment, as well as the total treatment zone (including the blend zone that feathers the treatment edges outside of the full optical zone area).

If the night vision problems persist, treatment is usually possible and will depend on the cause. Patience first though, as these symptoms can improve significantly yet. Give them the opportunity to assess and review your progress. Please let me know how you get on.