Innovations change face of modern cataract surgery

December 1, 2017

Eric Donnenfeld, MD, Robert H. Osher, MD, and Mark Packer, MD, review the year of cataract surgery advances and look to forthcoming developments.

By Cheryl Guttman Krader; Reviewed by Eric Donnenfeld, MD; Robert H. Osher, MD; and Mark Packer, MD

 

The year 2017 marked the 50th anniversary of phacoemulsification (phaco) and another year of innovations that continue to change the face of modern cataract surgery.

“Cataract surgery is the best operation in all of medicine, and it keeps improving,” said Robert H. Osher, MD, professor of ophthalmology, University of Cincinnati School of Medicine, and medical director emeritus, Cincinnati Eye Institute, Cincinnati, OH. “The changes may be incremental, but they add up to better safety, efficacy, and patient satisfaction.

“This last half century has been a tremendous time to be an ophthalmologist, and thinking back to 1983 when I decided to limit my practice to cataract surgery, makes me feel like I hit the lotto,” Dr. Osher added.

In reflecting on the year’s advancements, Dr. Osher, Eric Donnenfeld, MD, and Mark Packer, MD, spoke about recent and forthcoming developments in cataract surgery.

Manufacturers are persisting in their efforts to implement modifications to enhance the safety and performance of their phacoemulsification units, said Dr. Packer, president, Mark Packer MD Consulting Inc., Boulder, CO.

“We continue to see refinements in fluidics and power modulation,” he said, citing a new method of surge protection introduced for the Stellaris Elite (Bausch + Lomb). Known as Adaptive Fluidics, the system is designed to reduce IOP fluctuation and post-occlusion surge by varying infusion pressure in response to changes in vacuum levels.

“Rather than focusing on monitoring IOP and trying to respond to changes when they occur, the engineers at Bausch + Lomb have assumed surge will occur and developed a method for pumping in fluid in advance to lessen a fall in IOP that will lead to surge,” Dr. Packer said.

Dr. Osher noted that Alcon Laboratories introduced its new Intrepid Transformer I/A handpiece this year. The instrument is designed to enable easy transitioning from coaxial to bimanual cortical removal without changing handpieces.

He said he was excited about a new propeller turbo tip for torsional phacoemulsification and aspiration that was presented by Tadahiko Kozawa, MD, Japan, at this year’s meeting of the European Society of Cataract and Refractive Surgeons (ESCRS) in Lisbon. Dr. Kozawa won the grand prize at the meeting’s video competition for his film about the tip. It features a straight design with a propeller crossbar and takes cavitation from outside to inside the lumen, thereby eliminating repulsion of nuclear material and allowing for ultrasmooth emulsifying action.

Dr. Donnenfeld highlighted the FDA approval in October 2017 of the YAG nanolaser (Cetus, A.R.C. Laser) for cataract surgery.

“The laser emulsifies the lens with much less energy than conventional phacoemulsification, and the procedure it has been shown to be associated with less endothelial cell loss than phaco,” said Dr. Donnenfeld, clinical professor of ophthalmology, New York University, and founding partner, Ophthalmic Consultants of Long Island and Connecticut, Garden City, NY.

“Contact of the laser beam with the iris or capsule does not cause significant damage, and the laser can be used to strip the laminin layer from the capsule to prevent capsular opacification,” Dr. Donnenfeld added.

 

 

The future of femtosecond laser

Dr. Donnenfeld believes that with the improvements that have occurred over the years, femtosecond laser-assisted cataract surgery (FLACS) offers benefits for lens disruption and for creating more precise arcuate incisions, intrastromal incisions that cannot be performed manually, and more precise capsulotomies.

“As a new development this year, it was shown that the laser can make primary incisions with reverse sidecuts that self-seal better than keratome incisions,” Dr. Donnenfeld said.

Dr. Packer said the past 8 years in cataract surgery can be described as “the rise and fall of the femtosecond laser.” Keranova, a startup company in France, is working to develop a femtosecond laser for cataract surgery. The major existing manufacturers did not introduce any significant upgrades to their systems in the past few years, and only the two smaller manufacturers, LENSAR and Ziemer, seem to be showing any recent growth in sales, Dr. Packer said.

Still, Dr. Packer said he is not sure if the situation with FLACS should be viewed as the smoldering embers at the end of the campfire or if there will be a spark that will re-ignite the flames.

“In retrospect, we can say that the early critics of FLACS who raised concerns about anterior capsule tears and noted lack of improvement in functional outcomes swayed the market,” he said. “The technology may also have been a victim of the times, considering it was launched during an economic period when people were very cost-conscious.”

In October, Johnson & Johnson Vision received FDA clearance for the mobile patient bed for its Catalys Precision Laser System. The new bed is designed to optimize surgical workflow and integrates with the laser through Bluetooth connectivity.

LENSAR continued to expand integration between preoperative diagnostics and the femtosecond laser. In June 2017, it announced receiving FDA 510(k) clearance for the wireless integration of its laser with the Pentacam HR and Pentacam AXL tomographers (both from Oculus). The integration uses the Streamline III software from LENSAR and allows guidance of astigmatic incisions using the Pentacam parameters.

In November, LENSAR announced FDA clearance of Streamline IV, which includes capsular marks for orientation of toric IOLs based on iris registration from Cassini (iOptics), Pentacam, Aladdin (Topcon), or the OPD Scan (Nidek).

 

 

Diagnostics

Dr. Packer said the Pentacam AXL is novel-it is a complete biometer, providing anterior segment tomography data, posterior cornea surface measurements, and axial length.

“Surgeons who are doing refractive cataract surgery and who already have an optical biometer and a topographer may not be inclined to buy another expensive diagnostic instrument, but the Pentacam AXL may be of interest to someone whose old topographer is fading,” Dr. Packer said. “Calculating toric IOL power using actual posterior cornea surface measurements rather than a regression formula has been shown to improve refractive outcomes.”

For example, reported data show that the percentage of eyes left with <0.5 D of residual astigmatism is about 80% when surgeons use the Barrett Formula for toric IOL power calculations, but is above 90% using patient-specific posterior cornea astigmatism data and iris registration.

“The difference may seem small, but looking at it from another perspective, it means that for every 10 patients operated on, there is potentially one less unhappy patient,” Dr. Packer said. “For a surgeon who does a large volume of toric IOL cases, the numbers begin to add up.”

Dr. Osher gave rave reviews to the markerless Zeiss Cataract Suite system as a solution for making toric IOL alignment accurate and easy. With this system, the OCT alignment image acquired with the IOLMaster 700 is stored onto a thumb drive and imported into the Callisto eye.

The latter device matches the preoperative image to the patient’s eye and displays the target meridian as an overlay seen through the OPMI Lumera microscope.

“In my American Society of Cataract and Refractive Surgery (ASCRS) Innovators award lecture in 2009, I described techniques that would overcome the inaccuracy of ink markings for guiding toric IOL alignment,” Dr. Osher said. “Compared with what we have had, the markerless Zeiss Cataract Suite is just spectacular.”

For Dr. Donnenfeld, the most exciting advance in diagnostics software for cataract surgery is the cloud-based surgical planning platform developed by Veracity Innovations. The company was acquired by Carl Zeiss Meditec in August 2017.

“This system provides one-step access to all of our diagnostic instruments and uses advanced IOL formulas to provide surgeons with IOL and surgical technique recommendations for patients undergoing cataract surgery,” Dr. Donnenfeld said.

Dr. Osher said he was disappointed by the demise of Clarity Medical Systems in 2017.

“Intraoperative aberrometry-based aphakia refraction took a big hit this year with publication of a study in the British Journal of Ophthalmology that concluded the technique may not be feasible given the high rate of measurement failures and large variations of the readings,” Dr. Osher said.

In 2018, Alcon Laboratories is expected to introduce its ORA System with VerifEye Lynk. This new technology integrates the VERION image-guided system and ORA System technologies and introduces software updates designed to enhance preoperative measurements and planning, intraoperative guidance, and postoperative data analysis.

“Perhaps with better automation, integration, and with iris registration, which is now only available on the LENSAR laser, interest in FLACS will increase,” Dr. Packer said.

 

 

Using Callisto to center a Zepto capsulotomy with implantation of a Symfony IOL. (Video courtesy of Eric Donnenfeld, MD)

Advances in capsulotomy devices

Advances continued in the field of automated capsulotomy. The Zepto Capsulotomy System (Mynosys) received FDA 510(k) clearance in June 2017. Dr. Donnenfeld said it offers a very accurate way to make capsulotomies. As another advantage, the energy source hardens the capsule edge, making the capsulotomy stronger than a manual capsulotomy.

The thermal CapsuLaser (CapsuLaser) offers a similar benefit. It received the CE mark in 2017.

“CapsuLaser creates a fantastic capsulorhexis in just 1 second, and the treatment congeals the capsule collagen, which makes for a stronger rim,” Dr. Osher said. “The laser can also make a perfect posterior capsulorhexis that would allow posterior capsule capture of the IOL optic and consequently provide an effective strategy for eliminating posterior capsule opacification.”

 

Presbyopia correction

After receiving FDA clearance for marketing in July 2016, the Tecnis Symfony Extended Range of Vision IOL and Tecnis Symfony Toric IOL (Johnson & Johnson Vision) seemed to hit the ground running.

Dr. Donnenfeld considers the Symfony IOLs an enormous improvement in presbyopia correction.

“In the course of 1 year, this technology became the most used presbyopic IOL in the United States, and it has grown the market by 50%,” he observed. “The Symfony Toric IOL was the first diffractive toric IOL in the United States, and it is the only lens available here that corrects for chromatic aberration to improve contrast sensitivity.”

Dr. Packer thought that the trend for growth in Symfony IOL sales was slowing because of the realization that patients still can experience nighttime glare and halos.

“The Tecnis Symfony IOLs maintain an advantage over the other available multifocal IOLs in this regard, and they are definitely getting a lot of use,” Dr. Packer said.

During the ESCRS meeting, Dr. Packer said he conducted an informal poll of European surgeons to find out which of the many lenses that are available outside of the United States they prefer. The lens named most often was the Fine Vision trifocal, which seems to meet patients’ interest in achieving spectacle independence at all distances even though it does not overcome the problems of contrast loss and unwanted optical side effects.

“The trifocal design seems to be doing a better job than other lenses in eliminating the dip in the defocus curve at arms-length distance, which is right where the computer screen is,” Dr. Packer said.

The lens with the second-most mentions by European surgeons was the Acri.LISA multifocal (Carl Zeiss Meditec), followed by the Lentis MPlus (Oculentis). Dr. Packer noted that when the latter IOL was launched, there was some thought that it would be free of dysphotopsias, but symptom reports have emerged.

“It seems that whatever the optic design, surgeons implanting presbyopia-correcting IOLs should count on spending some extra chair time for patient selection and counseling, and anticipate some explantations in dissatisfied patients,” Dr. Packer said.

The trifocal PanOptix IOL from Alcon Laboratories will likely be the first trifocal IOL to come onto the U.S. market, he said.

 

 

Topical approach to presbyopia

Development of topical treatments for presbyopia is also continuing with two products in clinical trials-lipoic acid choline ester 1.5% (EV06, Novartis) and a formulation introduced by the late Lee Nordan, MD, known as Liquid Vision (Presbyopia Therapies). EV06 aims to restore crystalline lens flexibility. Liquid Vision combines a strong miotic (aceclidine) to create a superpinhole effect with a cycloplegic (tropicamide) to manage accommodation.

Looking ahead, Dr. Donnenfeld believes that there are also some promising accommodating IOLs in development, including the LensGen Advanced IOL (LensGen) and the FluidVision accommodating IOL (PowerVision).

 

Other IOL news

In 2017, Bausch + Lomb announced a new version of its enVista IOL-the MX60E-that features a new material with better unfolding characteristics.

“Surgeons will find that the new enVista unfolds just like a Tecnis or AcrySof IOL, if not a little easier, because it does not seem to stick at all,” Dr. Packer said. “This new material will be very important for getting predictable outcomes with a toric model.”

Dr. Osher noted that the small-aperture lens designed by Brazilian ophthalmologist Claudio Trindade, MD, for treating irregular astigmatism and/or intolerable glare (XtraFocus Pinhole Implant, Morcher) is coming to Europe. It is intended for ciliary sulcus implantation as a piggyback lens. The small aperture lies within a black hydrophobic acrylic material that blocks incoming visible light, but is penetrable by infrared light and so allows retinal examination. Dr. Osher performed the first implantation of this device in the United States and has been impressed with the outcomes.

European surgeons also saw the introduction of a disposable, preloaded, automated delivery system (AutonoMe, Alcon Laboratories) that allows one-handed insertion for the new Clareon IOL through an incision as small as 2.2 mm.

In the future, an adjustable IOL may be the best answer to addressing patient dissatisfaction related to residual refractive error, Dr. Osher said. One technology he is watching is the Perfect Lens that can have spherical aberration, asphericity, toricity, and multifocality adjustments made in vivo by treatment with a femtosecond laser.

 

 

IOL implantation techniques

Cataract surgery is also benefiting from innovations in techniques for securing the IOL in complicated cases. Dr. Osher said intrascleral haptic fixation introduced by Japanese surgeon Shin Yamane, MD, has garnered interest. At Dr. Osher’s 2018 educational meeting, Cataract Surgery: Telling It Like It Is, there will be four wetlabs teaching this sutureless method for securing a three-piece posterior chamber IOL

He noted that use of reverse optic capture for IOL stabilization has finally taken off. Testament to its growing popularity comes from consideration of the number of articles published about the technique in the past 12 months.

Coincident with this trend, Dr. Osher designed an instrument that makes it easy to prolapse the optic in front of the anterior capsulorhexis. The instrument is available from Bausch + Lomb as part of the “No Fly” set of surgical tools that Dr. Osher designed in response to the growing number of devices that are being placed under the operating microscope.

“These devices encroach on the sterile field and compromise the working space,” Dr. Osher said. “The No Fly instruments have shortened shafts, providing greater clearance, and are controlled using the fingertips instead of the hands.”

 

 

Pharmaceutical news

The focus on medication development for cataract surgery has turned to sustained-release delivery systems.

“Novel drug delivery devices continue to show promise for reducing or ending the need for topical drops in cataract surgery,” Dr. Donnenfeld said.

Dr. Osher agreed. He predicted that conventional topical medications will become obsolete with the advent of delivery systems that overcome the inefficiencies and compliance issues accompanying drops.

Ocular Therapeutix has completed phase III evaluation of a dexamethasone intracanalicular insert (Dextenza), and Mati Therapeutics is entering this space with a drug-eluting plug technology. Icon Bioscience has developed an intracameral sustained-release biodegradable formulation of dexamethasone that delivers the corticosteroid for several weeks. It has completed the phase III pivotal trials and submitted its NDA.

Dr. Packer wondered whether cost would limit adoption of these platforms. He said it will be interesting to see if manufacturers will be able to gain pass-through status for their products that are placed at the time of cataract surgery so that the cost is covered by Medicare.

Dr. Osher said that he was happy to see that adoption of phenylephrine and ketorolac injection 1%/0.3% (Omidria, Omeros) increased dramatically in 2017. He found the delayed uptake of the intracameral product for maintaining pupil size and reducing postoperative ocular pain puzzling, considering its efficacy, safety, pass-through reimbursement status, and the risks of using compounded alternatives. Now, however, he is waiting to see what happens after the pass-through status expires at the end of 2017.

“I and others have written letters asking CMS to grant separate reimbursement for Omidria, and hopefully that will happen,” Dr. Osher said.

 

Iris devices

Speaking of pupil management techniques, Dr. Donnenfeld said he has been using the I-Ring Pupil Expander (Beaver-Visitec International) and is finding this newest mechanical device very safe and effective.

“It is easily implanted and removed, and it is made of a soft polymer that is very gentle to the iris and seems to cause less iris sphincter tears than other devices I have employed,” Dr. Donnenfeld said.

Dr. Osher noted that an FDA-approved prosthetic iris device may be on the horizon as the CustomFlex Artificial Iris Implant (HumanOptics) is under review.

 

 

New surgical drape (Beaver-Visitec International) designed with minimal adhesive. Note the translucent material over the fellow eye that prevents claustrophobia.  (Photo courtesy of Robert H. Osher, MD)

Valuable additions

Dr. Osher mentioned he has introduced a clean air zone unit (Operio Mobile, Toul Meditech/Vitreq USA) into his operating room. The system uses laminar flow technology and a HEPA filter to produce an ultraclean airflow and is stationed near the patient’s head to maintain a sterile environment. Data collected using a particle counter show that it essentially removes all particulate matter, including lint and bacteria.

“In the past few years I noticed an unacceptable level of lint in the air in the operating room, and I even had a case where a patient developed a corneal abscess secondary to lint that had fallen onto the eye,” Dr. Osher said. “I saw this device at the ESCRS Congress in Copenhagen in 2016, and now I feel that I have the most sterile operating field in the United States.”

Hypersonic vitrectomy (Vitesse, Bausch + Lomb), available on the Stellaris Elite platform (Bausch +Lomb), also impressed Dr. Osher when he saw it on the exhibit hall floor at AAO 2017. It provides a cutting rate of about 1.7 million cuts per minute, creating hydraulic action to liquefy the vitreous outside the port, cutting the gel into small fragments that can be removed with lower vacuum and enabling more atraumatic vitrectomy.

Comparing hypersonic vitrectomy with conventional guillotine-style vitrectors, Dr. Osher said the difference would be the same as if he was comparing a modern jet aircraft with the first Wright brothers’ plane.

In the first quarter of 2018, a new surgical drape that Dr. Osher designed with Beaver-Visitec International will be released. The drape is made of a soft, pliable material, adheres to the skin with a minimum amount of adhesive, and has a translucent area over the unoperated eye to eliminate claustrophobia.

“Patients have told me that removal of the drape was the worst part of the operation for them because of the discomfort caused by the strong adhesive,” he said. “This new drape is painless.

“It also has a breakaway fluid collection bag and is shorter in length,” Dr. Osher said. “Therefore, it does not hang over the foot pedals and it allows the anesthesiologist and nurse access to the patient.”

 

 

Managing comorbidities

Glaucoma continues to merge with cataract surgery as more minimally invasive glaucoma surgery (MIGS) techniques are becoming available.

Dr. Osher said that the MIGS wetlabs at his meeting have been filled, and the 2018 program includes six wetlabs on MIGS.

The importance of identifying and managing ocular surface disease prior to cataract surgery is also getting growing attention.

“Perhaps cataract surgery is so good that it is hard to make it better,” Dr. Packer said. “Nevertheless, there is growing awareness that having a healthy ocular surface before surgery and after is important for optimizing outcomes.”

Long-term outlook

Dr. Osher noted that when he gave the Binkhorst Lecture at the ASCRS meeting in 2000, he predicted that a time would come that cataract surgery would hardly exist because technology would have advanced to a point that people would undergo a clear lens procedure to correct all refractive errors upon reaching adulthood.

Thinking about the progress that has been made, he remains convinced his forecast is correct. “Lens surgery has a very bright future,” Dr. Osher said.

 

Eric Donnenfeld, MD
e: ericdonnenfeld@gmail.com
Dr. Donnenfeld is a consultant to AcuFocus, Alcon Laboratories, Allergan, Aquesys, Bausch + Lomb, Beaver-Visitec International, Glaukos, Johnson & Johnson Vision, Novaliq, Ocular Therapeutix, 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 Bausch + Lomb, Beaver-Visitec International, Carl Zeiss Meditec, MicroSurgical Technology, and Omeros, and has equity interest in the Video Journal of Cataract and Refractive Surgery, which is a free service to ophthalmologists.

Mark Packer, MD
e: mark@markpackerconsulting.com
Dr. Packer is a consultant to Advanced Vision Science, Aerie Pharmaceuticals, Agility Clinical, Alcon Laboratories, Bausch + Lomb, Cassini BV, International Biomedical Devices, Keranova, LENSAR, Promedica, Rayner, Refocus, STAAR Surgical, and University of Colorado. He owns equity in Aerie Pharmaceuticals, Cassini BV, ClearSight, International Biomedical Devices, STAAR, and TrueVision.