14 Mar 2014
Clinical study of dynamic lens for treatment of presbyopia is under way in South Africa.
Ten patients have been implanted with a new kind of intraocular lens to treat presbyopia, as part of a multi-center clinical trial designed to assess its performance in patients undergoing cataract surgery.
According to PowerVision, the California-based company that is developing the novel fluid-controlled lens, the patients received their implants at the three eye centers in South Africa that are participating in the study.
Four sites in Germany are also participating in the trial and are expected to begin enrolling patients later this year. Eventually, 115 participants undergoing cataract surgery are expected to take part in the study, which will form the basis for a hoped-for CE mark approval of the “FluidVision” lens in Europe.
According to PowerVision, the lens has the potential to restore the eye’s ability to focus both up-close and at distance, something that diminishes significantly with age due to the effect of presbyopia – the loss of flexibility in the lens that makes short-range focusing more difficult.
The new intraocular lens contains a fluid that is said to move in response to the action of muscles in the eye. PowerVision says that it is able to mimic what optometrists describe as “accommodation” in a natural lens – the ability to dynamically change focus – by changing in thickness. It becomes thicker when the patient needs to see up-close, and thinner to focus in the distance.
It does this by using a proprietary hydraulic mechanism to drive fluid from the periphery of the device to the central lens portion and back again, changing the curvature of the anterior surface of the lens and therefore its optical power.
Corporate video: FluidVision intraocular lens
The trial follows on from a pilot study on 20 patients, and a $20 million round of financing that was completed by the company in late January. Eyecare giant Johnson & Johnson is among the company’s investors, who are targeting a presbyopia treatment market estimated by PowerVision to be worth a potential $5 billion per year in the US alone.
Gerd Auffarth, the principal investigator on the new study, is based at Ruprecht-Karls University Heidelberg in Germany. He said in a PowerVision statement: “Current treatment options that restore both near and far vision are limited. Results from an earlier pilot study of the FluidVision lens are quite encouraging, and we believe patients will benefit significantly from this lens, which has the potential to restore the eye's ability to focus clearly on objects near, far and in between.”
PowerVision's CEO and co-founder Barry Cheskin added: “We expect to complete patient enrollment this year and to receive the CE Mark sometime in 2015. Many millions of people around the world are impacted by cataracts and presbyopia and we believe there is a significant unmet need for more effective treatments of these clinical conditions.”
The South African part of the study will be carried out at three medical centers, in Cape Town, Johannesburg and Pretoria. In Germany, the participating sites are the Department of Ophthalmology at Ruprecht-Karls University Heidelberg, and clinics in Stuttgart, Bochum and Berlin.
The first part of the study should be finished by January next year, with full completion slated for mid-2017. For more details about the study visit the US National Institutes of Health (NIH) clinicaltrials.gov web site.