Features

Against the backdrop of this year's European Society of Cataract and Refractive Surgeon's conference in London, Mark Korolkiewicz offers some forthright views about the state of the UK industry

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The European Society of Cataract and Refractive Surgeons (ESCRS) Conference was held in London this September, and organisers were given the unenviable task of staging an event that lived up to the reputation established by previous hosts Paris, Lisbon and Nice. In terms of numbers, the event did not disappoint, with 5,000 delegates 4,000 of which were surgeons attending the event. This attendance is similar to that of the American version (ASCRS) for numbers of surgeons, although the ASCRS manages to attract around three times as many exhibitors.

INTRALASE

The ESCRS quickly confirmed femtosecond technology was rapidly gaining its place in the halls of refractive fame.

For those unfamiliar to the concept, it is a laser flap cutter. Depending on who you speak to, Intralase has now completed somewhere between 600,000 and 800,000 corneal Lasik flaps. High numbers of treatments from an accepted technology is not unexpected, but what puts Intralase in such a unique situation in modern refractive surgery is that in almost every other area, be it wavefront or tracking technology, there are numerous companies all claiming to be the best. Most companies have substance behind their claims, all have belief. Intralase and femtosecond, at least for the present time, is different. There is no other femtosecond that even comes close to Intralase for numbers of treated eyes, experience, data, or any other quantifiable parameter. This is very unusual.

Zeimer's Da Vinci and the Femtec's 20/10 are the only other commercially available options and both are embryonic by comparison. Both have FDA clearance, so they can sell in the US and both are CE marked, so they can sell in Europe. But neither have sold many products on either continent. Admittedly, the Femtec has other uses besides Lasik flaps, but from a refractive surgery point of view, their progress has been limited. Femtec are yet to treat any significant number of Lasik flaps in seeing eyes. Similarly, the Zeimer Da Vinci was launched at ASCRS in March this year. Clinical trials were due to commence at that time and the hope was clearly to create a tangible competitor to Intralase, and open up the lucrative femtosecond market. Da Vinci may yet succeed, but to date it appears only to have created flaps in a small handful of seeing eyes.

To be fair, some of the Swiss trials, such as Bojan Pajic's study at Vision Care in Olten, seem to show some fairly consistent flaps. But what must be remembered is that laboratory settings, limited trials and early days can only tell so much. Theoretical advantages regarding curved or straight cut interfaces, less suction applied to the eye, shorter working distances, lower energy levels creating more accurate cuts and numerous other discussions only become important when they deliver those advantages consistently and on real patients. Until Zeimer and Femtec start creating large numbers of flaps, we just won't know.

As if all this was not important enough, the Intralase profile was further boosted by the view, opinion and authority of Professor John Marshall. Individuals of this standing and reputation are a rare commodity.

A long-standing preference of surface treatment over Lasik appearing to shift the other way is persuasive. For years we have heard about 5 million collagen fibres being dissected in PRK compared to about a quarter of a billion with Lasik. If the Intralase is about to see such an eminent individual now favour laser-created flaps to surface, albeit laser cut and thinner, it's another piece of the evidence that just keeps mounting.

Laser-created flaps and, therefore, an all-laser Lasik procedure has few doubters as a concept, either publicly or privately. It seems only a matter of time before the first integrated excimer-femtosecond unit appears. Then things really will get interesting.

The future is bright for this technology no matter which way you look at it.

REGULATORY CONCERN

Regulation was bound to be a subject of discussion. The UK previously tried to deliver a 'world first' in the ill-fated Regulation of Laser Eye Surgery Bill before MPs found other things to do. The next attempt to create a 'world's first' now comes in the shape of the Royal College of Ophthalmologists' (RCO) voluntary assessment programme. In other words, an optional exam set by the RCO and taken by UK refractive surgeons. The RCO discussed its views during a session entitled 'Training refractive surgeons for the future'.

During the session, few appeared to appreciate the irony of an (albeit highly respected) vitreo-retinal surgeon discussing how best to improve standards and public safety of refractive surgery in the UK. One wonders how a refractive surgeon might be viewed doing the equivalent at a vitreo-retinal conference.

Another irony is why the RCO has paid so little attention to refractive surgery over the last 10 years, consistently offering little or no training to ophthalmologists, but is now determined to create an examination to improve public safety in the field.

If such action was genuinely necessary - and this is not a certainty given other countries manage quite well without it - would it not be a case of closing the stable door after the horse has bolted? While the politics of who should set the proposed exam would rival anything Westminster has to offer, the logic of the exam itself is questionable, given it is entirely voluntary and therefore unlikely to interest those surgeons the public presumably needs protecting from.

Even so, the RCO should at least be applauded for supporting training modules for ophthalmologists. Refractive laser eye treatment is being undertaken about 150,000 times a year in the UK alone. The RCO supports the notion of providing refractive surgery knowledge for all its members during their time training. Sadly, this leaves the General Optical Council and College of Optometrists doing nothing to ensure qualifying optometrists can accurately advise the general public on refractive surgery.

INTRAOCULAR APPROACH

Intraocular lenses (IOLs) continue to be the subject of much discussion at these events. Almost mirroring the generally decreasing ranges treatable with a laser over the last few years has been the technological advances in non-corneal options.

Multifocal and aspheric lenses were given particular attention. Public health systems allowing certain types of 'premium lenses' to be fitted on both sides of the Atlantic have played their part in changing this area of the industry.

An impressive study by Werner Hutz of the Klinikum Herfeld in Germany showed some impressive near vision reading speeds in low light with multifocals such as the Tecnis and AcriTwin lenses. Despite multifocal IOLs volumes appearing to level out from earlier impressive levels of growth, there is still much enthusiasm for these lenses.

The evidence that aspheric lenses are producing superior vision quality to standard lenses builds. The three main players all have lenses with impressive results. Alcon's Acysoft IQ, Bausch & Lomb's Akreos AO and AMO's Tecnis Z-9000 all appear able to show improvement to postoperative spherical aberrations compared to standard lenses, meaning better low-light contrast sensitivity and therefore improved vision.

A study by Louis Nichamin, of Brookville in the US, demonstrated a superior contrast sensitivity with the B&L aspheric SoftPort AO and, interestingly, the negatively aspheric AMO Tecnis, compared to a conventional acrylic lens. Controlling the effect of overall postoperative aberrations may well have benefits for patients' quality of vision.

CONDUCTIVE KERATOPLASTY

Conductive keratoplasty (CK) has been going through something of a shift of acceptance at recent conferences (see page 30). It still seems the preserve of a relatively small number of surgeons, at least certainly when compared to how many surgeons use a laser. The small group of CK surgeons is increasing, and will continue to do so with longer-term data becoming available and variations in technique showing advantages. Generating unwanted postoperative astigmatism has always been the limiting factor, but Justo Allande's impressive study from the Hospital J B Iturraspe, Santa Fe, Argentina, suggests this need not be the case. The study of 3,500 CK treated eyes and numerous technique refinements including 'light-touch' appeared to address the previous difficulties and produce some excellent results.

Overall, the ESCRS was a highly useful conference. There appears to be a greater level of certainty of direction than in previous years. The development and refinement of wavefront-related algorithms will continue to improve treatment profile, but another entity such as wavefront itself is unlikely.

When it comes to Lasik, there is likely to be improvement of existing technologies rather than the introduction of new innovations. Femtosecond will develop and undoubtedly become integrated with excimer, as moving a treatment bed between two separate lasers can't make sense forever. Nor can buying two lasers for that matter. But the question over whether femtosecond could actually correct the prescription as well as creating a flap still remains.

It is not possible just yet, but the stoney silence from most reps when asked would suggest it is at least being worked on. Laser treatment parameters will be likely to continue be eaten away at the edges as the conservatism continues, albeit at a slowing rate, and IOL techniques improve to make the choice simpler.

And one last thing is for certain. While the rest of the world gets on with other things, the various UK refractive factions will continue arguing and debating over training, regulation and self-interest in a schoolyard fashion. For that at least we will always be the 'world's first'.

◆Mark Korolkiewicz is the clinical services director of Ultralase

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