Approval of a new class of implants tops cataract surgery news

December 1, 2016

Cataract surgeons in the United States have long been envious of the IOL options available to their international colleagues. Finally, in 2016, American ophthalmologists gained access to some novel IOLs such as the Tecnis Symfony Extended Range of Vision IOL and the Tecnis Symfony Toric IOL (Abbott) that were approved by the FDA. According to leading cataract surgeons who spoke to Ophthalmology Times, these simultaneous approvals rank as the biggest cataract surgery news story of the year.

Cataract surgeons in the United States have long been envious of the IOL options available to their international colleagues. Finally, in 2016, American ophthalmologists gained access to some novel IOLs such as the Tecnis Symfony Extended Range of Vision IOL and the Tecnis Symfony Toric IOL (Abbott) that were approved by the FDA. According to leading cataract surgeons who spoke to Ophthalmology Times, these simultaneous approvals rank as the biggest cataract surgery news story of the year. 

“The approval of the Symfony and Symfony Toric IOLs was an important event because these implants represent a whole new class of presbyopia-correcting lens technology, and it is also exciting because the Symfony Toric is the first toric non-accommodating presbyopia-correcting IOL,” said Dr. Donnenfeld, clinical professor of ophthalmology, New York University, New York, and founding partner, Ophthalmic Consultants of Long Island and Connecticut, Garden City, NY.

The Symfony IOLs have several appealing features and he predicted their availability would lead to a significant increase in uptake of advanced technology IOLs.
“In the FDA trials and in my clinical experience, problems with glare and halo are minimal with the Symfony IOLs and are much less than previous generation multifocal IOLs, and that reduces the risk of patient dissatisfaction. In addition, the Symfony IOLs are easy to implant and very forgiving of residual cylinder and hyperopia in terms of providing excellent distance vision,” Dr. Donnenfeld said.

Mark Packer, MD, offered similar thoughts. “The Symfony IOLs are associated with less halos and glare than the progenitor platform, the Tecnis Multifocal IOL (Abbott), and they can provide 20/20 UCVA at distance and J1 at 16 to 18 inches, which is pretty strong in terms of presbyopia correction,” he said.
However, Dr. Packer pointed out that the Symfony IOLs perform less well for providing excellent uncorrected near vision, and that the technology does not completely eliminate dysphotopsias. Therefore, surgeons must be careful to mention the risk when counseling patients.
“Twenty years ago when the Array multifocal IOL (Abbott) was introduced, some surgeons were telling patients they would not experience any visual disturbances with the lens. I hope we have learned a lot since then because any optic that features a diffractive element has the potential to cause halos and glare. When people are forewarned and anticipate a possible problem, they are more likely to accept it and remain satisfied than if it comes as an unanticipated surprised,” said Dr. Packer, clinical associate professor of ophthalmology, Oregon Health & Science University, Portland.

He noted that cataract surgeons outside of the United States may prefer trifocal IOLs over the Symfony implants because the trifocals provide better near vision. The only presbyopia-correcting toric competitor for the Symfony Toric IOL in the United States is the Trulign Toric IOL (Bausch + Lomb). However, its performance also falls off at near. And compared with the Symfony, surgeons need to pay a little more attention to detail when implanting the Trulign and provide closer follow-up to monitor for capsular contraction.
“The Trulign gives great distance and intermediate correction, and near vision performance can be optimized by using monovision or a modified monovision approach. Otherwise, J5 is the average UCVA at near with the Trulign, which means near vision is worse than that in half of people who are implanted with the lens,” Dr. Packer said.

“In addition, tilting, or the so-called Z-syndrome, remains a nagging concern with this lens, and many surgeons are performing anterior capsulotomy early to avoid that problem,” Dr. Packer said.

Accomodating and adjustable IOLs

 

Accommodating and adjustable IOLs

Research is continuing in the development of accommodating IOLs, including the FluidVision accommodating IOL (PowerVision) and the LensGen Advanced IOL (LensGen). PowerVision has designed a fifth-generation version of the FluidVision accommodating IOL that is expected to be brought forward into U.S. clinical trials. The FluidVision lens is shape-changing technology that creates accommodation through a natural mechanism. It is a silicone oil-filled implant with reservoir haptics that move the fluid into the optic upon ciliary muscle contraction, resulting in an optic curvature change for better near vision. Once the eye relaxes from accommodation, the oil goes back into the haptics and the curvature changes to provide distance vision.

The LensGen Advanced IOL comprises a fixed-optic base that receives a fluid-filled lens. The system also responds to ciliary muscle contractions with deformation of the fluid-filled component.

In the United States, the Light Adjustable Lens (Calhoun Vision) designed for in vivo modification is still being evaluated in the Phase III study. Perfect Lens is also continuing to develop its refractive index shaping lens that would allow in vivo refractive adjustments and the ability to add or remove multifocality. The platform is based on the use of a femtosecond laser to change the refractive index of the IOL material.

 

Other novel IOLs

Robert H. Osher, MD, described the small aperture lens (XtraFocus Pinhole Implant, Morcher) for treating irregular astigmatism and/or intolerable glare as one of the most exciting IOL stories of the year. Invented by Brazilian ophthalmologist Claudio Trindade, MD, it is intended for ciliary sulcus implantation as a piggyback lens. The device is made of a black hydrophobic acrylic which blocks visible light.

The small pinhole aperture minimizes the negative impact of corneal optical aberrations on image resolution by excluding peripheral ocular light rays.
“This is a phenomenal device, and I have had wonderful experience with it,” said Dr. Osher, professor of ophthalmology, University of Cincinnati School of Medicine, and medical director emeritus, Cincinnati Eye Institute, Cincinnati, OH.

Discussing another Morcher product, Dr. Osher said one of the most gratifying experiences for him during the year came with the opportunity to resolve debilitating dysphotopsias for a patient through implantation of a custom-made black IOL.

“The patient was suffering because of radiation retinopathy, and she was so unhappy that she asked about enucleation. Implantation of this custom light-occluding lens allowed her to keep her eye,” he said.
Dr. Osher also cited introduction of the RayOne hydrophilic IOL (Rayner) in Europe as an important event. This fully preloaded microincision IOL is newsworthy for several reasons. The lens is ready for implantation with solely the insertion of ophthalmic viscoelastic device (OVD) into the cartridge and therefore reduces handling-related risks of lens damage and contamination. In addition, the injection system nozzle measures only 1.65 mm in diameter.

“It seems the Europeans are ahead of us in developing sub-2 mm injection technologies as evidenced by another company, Benz RD, with their new hydrophobic lens,” Dr. Osher said. Another unique feature of the RayOne system is the accompanying OVD containing sorbitrate, which acts as a free radical scavenger.

“The addition of sorbitrate is a story in itself because it could help to protect against corneal endothelial damage from reactive oxygen species generated by acoustic cavitation during phacoemulsification,” Dr. Osher said. “The idea of using a free radical scavenger intraoperatively originated with Ehud Assia, MD, who began using ascorbic acid in the irrigating solution. Rayner is taking a fresh new approach by including the free radical scavenger in the OVD that is injected into the lens cartridge.”

Better refractive outcomes

 

Better refractive outcomes

Developments are also continuing in IOL power calculation methods. To enable attainment of better results for patients implanted with the AcrySof Toric IOL, Alcon introduced an updated version of its Online Toric Calculator. The new formula is based on the Barrett Toric Algorithm which takes into account posterior corneal astigmatism.

“At the 2016 ASCRS Symposium, Elizabeth Yeu, MD, presented a study showing that the best results after toric IOL implantation can be achieved using actual measurements of the posterior cornea. She reported by using that approach, utilizing Cassini Total Corneal Astigmatism (iOptics, the Netherlands), astigmatic error was less than or equal to 0.5 D in 94% of eyes,” Dr. Packer said. “However, use of a calculator that takes the posterior cornea curvature into account is better than ignoring its contribution completely, and may be an appealing alternative for surgeons unable to afford a new imaging device that can directly measure the posterior cornea.”

Dr. Osher noted the availability of a new formula developed by Warren Hill, MD, as a joint project with the Radial Basis Function Calculator Physician Team and Mathworks. Known as the Hill-RBF Calculator, it is a method based on artificial intelligence and pattern recognition.

“This is an entirely new approach unlike anything we have had before,” Dr. Osher said.

 

IOL-related perspectives

With the availability of the Symfony Toric IOL and advances in toric IOL power calculators and diagnostics for measuring posterior cornea power and guiding toric IOL alignment, Dr. Osher predicted an increase in toric lens penetration, which has been dismally low. He also noted Alcon is taking a unique approach to stimulate toric IOL uptake through a multimillion dollar direct-to-consumer campaign.

“A lot of cataract surgeons have been reluctant to offer toric lenses to patients. I think Alcon’s motivation is to raise public awareness in order to increase demand,” Dr. Osher said.

Recent personnel changes at Zeiss may foreshadow some interesting future developments in the United States IOL market, he added. The hiring of two American industry leaders-Jim Mazzo as head, Strategic Business Unit Global Ophthalmic Devices, and Andrew Chang, MD, who was brought in to lead the Global Sales organization for the newly consolidated Strategic Business Unit comprised of Surgical Ophthalmology, Ophthalmic Diagnostics, and Refractive Lasers-has generated speculation that Zeiss may be looking to bring its own IOL line into the United States or at acquiring a company with products already in this space.

J&J's AMO acquisition

 

Dr. Packer suggested that the acquisition of Abbott Medical Optics by Johnson & Johnson may be good news in terms of greater marketing support for the Symfony IOLs. He also noted he was somewhat surprised that the Symfony IOL approvals came without an FDA Advisory Committee meeting. He suggested, however, that the Symfony benefited from an earlier FDA-American Academy of Ophthalmology workshop on developing novel endpoints for premium IOLs combined with its strong efficacy and safety data.

Finally, Dr. Packer noted that the approval of the Symfony IOLs may also be important for driving overall innovation in the field of cataract surgery and adoption of technologies, including the femtosecond laser and new diagnostics that contribute to better refractive outcomes

“When patients choose a premium lens, they are paying out-of-pocket fees that will help cover the costs of using the expensive new technologies,” he said.

 

Eric D. Donnenfeld, MD  

E: ericdonnenfeld@gmail.com

Dr. Donnenfeld is a consultant to Abbott Medical Optics, AcuFocus, Alcon, Allergan, Aquesys, Bausch + Lomb, Beaver Visitec International, CRST, Glaukos, Novaliq, Omeros, Pfizer, and Shire Pharmaceuticals. He consults and has investment interests in Katena, Novabay Pharmaceuticals, PRN Pharmaceuticals, and RPS Diagnostics.

 

Robert H. Osher, MD

E: rhosher@cincinnatieye.com

Dr. Osher is a consultant to Alcon Laboratories, Bausch + Lomb, Beaver Visitec International, Carl Zeiss Meditec, Clarity Medical Systems, MicroSurgical Technology, Omeros, and the Video Journal of Cataract and Refractive Surgery.

 

Mark Packer, MD

E: mark@markpackerconsulting.com

Dr. Packer is a consultant to Advanced Vision Science, Alcon, Allergan, Bausch + Lomb, Cassini BV, International Biomedical Devices, LensAR, Rayner, and STAAR Surgical, and he owns equity in Cassini BV, International Biomedical Devices, LensAR, and TrueVision.