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Santen introduces the xact™ Mono-EDoF™ in Europe – the monofocal IOL with true extended depth of focus

Mon 16 September, 2019

  • CE marked and approved as a monofocal hydrophobic intraocular lens (IOL), the xact™ Mono-EDoF™ is a hydrophobic diffractive IOL with 4 diffractive rings developed by Santen1
  • Provides excellent visual acuity at far distances as expected from typical monofocal IOL, and additionally offers functional visual acuity at intermediate distances, thanks to its novel continuous range of focus optical design, with no significant visual side effects (e.g. halo and glare) similar to typical monofocal IOLs2

Geneva, Switzerland – Santen EMEA announces the European launch of its novel, monofocal, hydrophobic IOL that clinically demonstrates extended depth of focus.1

For ophthalmologists, this new breed of monofocal lens will mean the ability to offer their patients more than just standard vision correction following cataract surgery. Historically, patients have been treated for distance vision and have needed reading glasses to see up close. For patients, the implanted xact™ Mono-EDoF™ should reduce their dependence on glasses after cataract surgery, without the visual trade-offs seen with standard EDoF (extended depth of focus) IOLs.2

“The xact™ Mono-EDoF™ IOL allows surgeons to offer their patients visual correction that provides a wider range of vision,” said Mark Packer, MD, Boulder, Colorado, who serves as the medical monitor for the xact™ Mono-EDoF™ IOL clinical studies. “The ability to offer patients outstanding intermediate and far distance with minimal side effects is really exciting.”

The xact™ Mono-EDoF™ IOL has a broad single peak of focus rather than the bimodular peak seen in typical EDoF lenses.2 In European clinical studies, decfocus curve tests showed that the xact™ Mono-EDoF™ demonstrated a continuous range of focus from far to intermediate. This demonstrated improvement in uncorrected intermediate vision which is especially important in the digital age, where tablet and phone device use is on the rise.1

In addition to exceptional uncorrected intermediate and distance vision, xact™ Mono-EDoF™ IOL patients report contrast sensitivity equivalent to a monofocal IOL, with a higher tolerance to the effects of decentration and tilt compared to a conventional EDoF IOL. In addition, patients reported minimal visual side effects, such as glare and halo in European clinical studies.1

“Patients completed a questionnaire before surgery and after surgery about their vision. After surgery, the patients reported very good daytime vision, but they also reported a significant improvement in their night-time driving vision, similar to what we see in patients with monofocal IOLs.” explained Prof. Gerd U Auffarth, Chairman of the Department of Ophthalmology at the University of Heidelberg and a recognised expert in the field of EDoF IOLs.

“I think it’s a lens with a lot of potential because it’s very forgiving, it has excellent distance outcomes, and it gives patients true intermediate vision without side effects,” added Dr Florian Kretz, Rheine, Germany, the first surgeon in the world to implant the IOL.

Manufactured using Santen’s proprietary hydrophobic acrylic material, the xact™ Mono-EDoF™ IOL will be featured at the Santen booth at the European Society of Cataract & Refractive Surgeons (ESCRS) congress in Paris from 14-18 September, as well as during a symposium entitled New concept monofocal IOL with continuous focus on Monday 16 September (18:15-19:15), in West 1, Paris Expo, Porte de Versailles.

Santen plans to introduce the xact™ Mono-EDoF™ IOL in individual countries over the remainder of 2019 and into 2020.

References:

  1. Baur I et al. Klinische Erfahrung mit einer neuen monofokalen Intraokularlinse mit erweiterter Tiefenschärfe. Presented at the 32nd Annual Internationaler Kongress der Deutschen Ophthalmochirurgen. Nuremberg, Germany, 24 May 2019.
  2. Spalton DJ et al. Optical and Clinical Comparison of a Novel Monofocal Extended-Depth-of-Focus IOL and a Conventional Bifocal Extended-Depth-of-Focus IOL. Presented at American Society of Cataract & Refractive Surgery, San Diego, US, 4 May 2019.

 

Job code: PP-IOL-EMEA-0001

Date of preparation: September 2019