The numbers can be overwhelming: 1.8 billion people globally were living with presbyopia in 2015, 826 million of whom had near vision impairment because they had no, or inadequate, vision correction.1 Further, the global unmet need for presbyopia correction stands around 45%.1 In the US, it is estimated 123 million people will have presbyopia by 2020.2
The correction of presbyopia remains ophthalmology’s “Holy Grail,” and numerous companies are on the technology horizon attempting to achieve just that.
At this year’s OIS@AAO breakfast breakout session, moderator Elizabeth Yeu, MD, and panelists Steven Smathers of Perfect Lens, Yari Mitchell of AcuFocus, Max Wolf, MD, of Alcon, and Ramgopal Rao of LensGen talked about how the landscape has changed for the treatment of presbyopia.
Changing existing technology
Perfect Lens has developed the technology and a device that “allows the physician to alter the refractive index or the refractive characteristics on the implanted IOL,” said Smathers, president and CEO of Perfect Lens. “We give the physician the ability to change an implanted monofocal lens into a multifocal lens.”
The device recognizes the type of intraocular lens (IOL) in the patient’s eye. The laser applies femtosecond energy to alter the sphere or cylinder, or both. The technology can add or remove multifocality because its design is chemistry-based, Smathers said. Of additional benefit, the technology is not limited to one-time use, but allows an IOL to be adjusted numerous times, “because you’re adding water to the lens at different spots,” he added.
Explaining the technology a bit more, Smathers noted: “We use the energy from the femtosecond laser to create a two-photon reaction within the acrylic material. You’re breaking some ester bonds and creating some residual alcohol and acid molecules. Those acid and alcohol molecules are hydrophilic. They’ll attract the water and lock it into the acrylic structure; the refractive index of that particular material is now permanently altered. The change is consistent and remains that way as long as the material is in some kind of oculus environment.”
The 60-second procedure is an in-office treatment, Smathers added. In vitro studies have not created any inflammatory reactions. In response to an audience query, he noted some IOLs with UV absorbers become more reactive, but in general every lens will be able to undergo the procedure.
Using well-known technologies
With a commercially marketed technology, AcuFocus has concentrated on embedding a small aperture inside an aspheric monofocal IOL. It results in restriction of peripheral de-focused light rays, allowing only the central light to reach the retina, said Mitchell, VP, global medical affairs and business strategy. The same amount of light energy is delivered to all focal distances and elongates that depth of focus in the IC-8 IOL.
Postmarket research in Europe found binocular uncorrected visual acuity was maintained “with no degradation in range of vision or visual performance” over several years, Mitchell explained. Of current interest, she said, is the data on corneal astigmatism for the IC-8 IOL.
“We can see that for patients with up to 1.5D of corneal astigmatism, there’s no change in visual performance between any focal point from distance, intermediate, or near,” she said; there is a “bit of a drop off” in patients with >1.5D of corneal astigmatism.
The IOL is CE marked, and while AcuFocus intended the IC-8 to be used unilaterally (with a monofocal in the contralateral eye), some surgeons are opting for bilateral implantation (mostly in patients with highly aberrated corneas) with real reductions in dysphotopsia. The lens may also benefit those with post-LASIK or post-radial keratotomy, keratoconus, or ocular trauma.
Innovation in the Surgical Suite
Diagnostics are “going to become much more sophisticated than what you see today, providing us information and parameters that we may not even envision today but are essential to deliver things like accommodating lenses,” predicted Dr. Wolf, global head, intraocular lenses for Alcon.
He noted that the innovation in IOL technologies, including the introduction of trifocal and extended depth-of-focus lenses, and intraoperative aberrometry are just the beginning. Accommodating lenses “will be coming sooner rather than later, but what may surprise you is that the bar for accommodating lenses is actually getting higher and higher” thanks to the introduction of trifocals, Dr. Wolf added. Alcon’s PanOptic lens (not available in the US) provides 20/25 or better vision across the entire range of vision.
“When you connect these technologies, and connect them with your electronic medical records system, you now have powerful artificial intelligence behind them,” he continued. In collaboration with Philips, Alcon recently introduced the SMART Suite, a digital health platform for cataract surgery. Dr. Wolf said its open, cloud-based infrastructure allows for a seamless transition of data throughout the cataract surgery by combining the Alcon cataract suite with an existing electronic medical records system.
“The efficiency is there, the speed is there, the error reduction, but when you put artificial intelligence behind all that data, who knows how far that can take us,” he commented.
The Complete IOL
Surgeons and patients alike want dynamic, continuous correction of –2D or more, good contrast sensitivity and optical quality, plus the ability to reach emmetropia with minimally induced astigmatism.
“We need lenses that produce less glare and halo; we need to resolve those issues,” said Rao, LensGen CEO. To that end, the company has developed Juvene, a curvature-changing fluid IOL designed to provide dynamic and continuous focus. Defocus curve pilot studies have shown this lens “significantly outperforms a leading extended depth-of-focus [EDOF] lens at near by about 3 lines, and has the same outcomes as the EDOF lens at intermediate and distance,” he said.
Juvene works “more like natural accommodation; we insert the base lens first and then we insert the fluid lens, and then the accommodating forces are applied to the capsule and the compression causes accommodation,” Rao explained. He added that pilot studies have shown stable effective lens position, stable refraction, minimal IOL rotation, negligible posterior capsule opacification (with data out to 33 months), and less vitreoretinal tension.
The company plans to start FDA clinical trial enrollment in late 2019/early 2020.
A copy of the presentation from the presbyopia breakout session is available here.
For questions about this article, please contact Michelle Dalton at email@example.com.
- Fricke TR, Tahhan N, Resnikoff S, et al. Global Prevalence of Presbyopia and Vision Impairment from Uncorrected Presbyopia: Systematic Review, Meta-analysis, and Modelling. Ophthalmology 2018;125(10):1492–1499. doi: 10.1016/j.ophtha.2018.04.013. Epub 2018 May 9.
- Alcon Inc. August 6, 2013. Presbyopia Poised to Become Global Vision Correction Issue for People Over the Age of 40. Press release available at: https://www.alcon.com/news/media-releases/nearly-11-million-people-united-states-have-eye-condition-known-presbyopia Accessed November 19, 2018.