Artiflex Toric: will it hit the mark?

Key Points

Phakic IOLs: the debate

With Europe as the worldwide leader, in terms of both innovation and experience, in phakic IOLs, it is unsurprising that much of the debate occurs here. Certainly, phakic IOLs have several noticeable advantages over laser refractive surgery. Primarily, phakic IOL implantation can be tweaked or reversed in cases of complications or failure, whereas laser refractive procedures are irreversible. Phakic IOLs also tend to produce higher levels of refractive correction.

Nevertheless, phakic IOLs continue to evolve. The new generation of IOLs is safer, easier to implant and more efficacious than ever before, demonstrating a lower incidence of the most prominent complications, including endothelial damage. Thanks to the introduction of foldable toric IOLs, even induced astigmatism has been almost eradicated.

One such example is the Artiflex Toric IOL (Ophtec BV), which is expected to launch later this year. This lens is the latest extension of Ophtec's proven Artisan concept and is based on the same fixation method as the original, designed by Jan Worst, MD in 1978.

The predecessor: Artiflex phakic IOL

In March 2007, Ophthalmology Times Europe reported on the Artiflex European multicentre study led by Dr Milan Izàk, of the Eye Clinic F.D. Roosevelt Hospital, Slovak Healthcare University in Banskà Bystric, Slovakia.¹

Dr Izàk implanted the lens in 50 eyes of 29 patients between June 2004 and August 2005; follow-up data were collected at three, six and 12 months, with the team monitoring spectacle dependency, visual acuity, endothelial cell loss, laser flare photometry and incidence of complications.

At 12 months, the team found that two eyes had gained three lines of vision, 10 eyes had gained one line and the remaining eyes showed no change, although only 6% remained spectacle dependent and 80% were completely independent of spectacles. Additionally, this lens was associated with only 2.89% endothelial cell loss at 12 months and was not associated with haemato-ocular barrier break or chronic inflammation. Two subjects suffered iritis with transient intraocular pressure (IOP) elevation, which was relieved by seven days' local steroid treatment.

In light of this success rate and low incidence of minor complications (with a complete absence of significant complications), the next generation Artiflex Toric IOL is well placed for market launch.

Artiflex Toric IOL design and study

Camille Budo, MD, associate professor at the Academic Eye Clinic in Maastricht, The Netherlands, has been working with Ophtec and Professor Worst for more than 20 years, and has been instrumental in the development of the new Artiflex Toric IOL. Dr Budo is the main investigator leading a multicentre study, examining the safety and efficacy of the Artiflex Toric IOL, which is indicated for the treatment of low, moderate and high myopia.