Rayner bets on ePRO

Howard Larkin

Posted: Friday, December 7, 2018

Rayner CEO Tim Clover

Valuable as they are, tests of visual acuity and target refraction after cataract surgery don’t tell the whole intraocular lens (IOL) outcomes story. Patient satisfaction and function, such as spectacle independence and night vision, are also important, as are long-term visual outcomes and complications, such as posterior capsule opacification (PCO).

Yet gathering such data can be difficult and time consuming, noted Tim Clover, CEO of Rayner. So the Worthing, UK-based firm – which is the worlds’ first IOL manufacturer – developed RayPRO, a mobile phone and web-based app for collecting patient-reported outcomes (PROs) for three years after surgery. The goal is to paint a more complete portrait of patient satisfaction for purposes of quality improvement, demonstrating value to purchasers and complying with new EU rules for post-market tracking of medical device performance.

Previewed at the 36th Congress of the ESCRS in Vienna, Austria, RayPRO was developed specifically for cataract surgery and is available free of charge to all users of Rayner IOLs. “Every Rayner IOL now comes with up to three years’ follow-up data that surgeons can use to better understand how their work translates to patient satisfaction,” Clover said. RayPRO will be available in Android and Apple versions and through web browsers in English, French, German, Italian, Spanish and Portuguese from January 2019, but interested users are able to sign up now on the website

Surgeons register patients at the time of surgery, and patients then receive five questionnaires by email over three years. These include questions about satisfaction with the surgeon and hospital one week after surgery and satisfaction with surgery outcomes, spectacle independence at various distances and achievement of target refraction three months after surgery.

Satisfaction with surgery outcomes and any visual disturbances are checked at one year. At one, two and three years after surgery patients are asked about the need for any additional procedures, such as Nd:YAG capsulotomy or a laser refractive correction, in the previous 12 months.

Surgeons can access RayPRO information any time via an online dashboard that includes both their individual outcomes and a ranking of a surgeon’s composite RayPRO performance score – which combines satisfaction and refractive target attainment measures – compared with peers by country, continent or worldwide, Clover said.

To protect patient privacy, data are anonymised, and surgeons can only access their own individual data. However, the data can be used to support surgeon’s recertification and audit requirements, and may be helpful for promoting services to new patients.

Clover anticipates that RayPRO data from hundreds of thousands of patients will help Rayner improve its products as well, shedding light on questions such as what factors might lead to PCO or lens dislocation. “With tens of millions of cataract surgeries every year, basing decisions on clinical studies covering 50 to 100 patients isn’t sufficient,” Clover said.

Rayner also unveiled the first trifocal supplementary IOL at ESCRS 2018 Vienna. Designed for placement in the sulcus, the Sulcoflex Trifocal brings the benefits of improved near and intermediate vision to patients who already have a monofocal aspheric or monofocal toric lens implanted in the capsular bag, Clover said.

The Sulcoflex Trifocal employs optics improvements first released in the RayOne Trifocal capsular bag IOL last year, Clover said. These include minimising the number of diffractive steps to reduce visual disturbances such as glare and halos, and 89% light transmission to the retina to improve contrast sensitivity and low-light performance. Early surgery reports suggest the lens is easy to implant and may provide better centration than capsular bag-fixated lenses, which is critical to achieve peek optical performance with multifocal lenses.

Earlier this year Rayner launched its first hydrophobic acrylic IOL, the RayOne Hydrophobic. Made of an ultra-purified proprietary material, the new lens virtually eliminates vacuoles and the associated “glistenings” seen in some hydrophobic lenses, Clover said. This reduces light scatter and improves optical performance.

The 6mm lens is preloaded in Rayner’s RayOne injector allowing smooth delivery through a sub-2.2mm incision. Clover believes these favourable qualities will give Rayner an edge as it enters the hydrophobic IOL market, which makes up about two-thirds of global IOL sales, Clover noted.

These new products are driving compound sales growth of more than 20% annually, Clover said. They result from a renewed focus on IOL innovation since Rayner shed its optical shop operations when Clover took over as CEO in 2015. Since then Rayner has made five acquisitions, partnered with surgeons and university researchers and hired 10 PhDs and engineers focusing on commercialising new products.

As a private, independent company all Rayner profits go into R&D to further improve product performance, Clover said. “Our strategic aspiration is to improve visual outcomes with our unique combination of IOLs, OVDs, Corneal Pharma and RayPRO system. We have no interest in going into the phaco or diagnostic machine market. We want to be the IOL partner of choice for cataract surgeons all over the world.”