When we accepted the invitation to write this article, we envisioned a typical review of current and soon-to-be available vitreoretinal surgical technologies. We would reach out to a few companies, demo new devices and present our opinions. The COVID-19 pandemic changed our plans. We’ve spent little time in the operating room, our cases have been limited to immediately vision-threatening emergencies and this is not a good time to evaluate new devices. Fortunately, restrictions on elective surgeries have started to relax and we are returning to a more normal OR schedule.
However, we also recognize that COVID-19 will change the way retina specialists practice for the foreseeable future. With that in mind, we presented a set of questions to a number of companies our specialty relies on for tools and will share our observations.
HAS THE COVID-19 PANDEMIC CHANGED YOUR PRIORITIES FOR PROMOTING OR INTRODUCING NEW VR TECHNOLOGIES?
Safety and support
The consensus amongst our industry partners is that they prioritized keeping their employees and VR surgeons safe from the virus. Companies have established strict social distancing protocols as well as disinfection and preventative guidelines to protect their supply chain.
“Rather than promotion, our focus has been on supporting physicians in other ways like reimbursement support around using telemedicine, providing clarity on the CARES Act and virtual learning opportunities like the Alcon Experience Academy,” said Mike Lee, U.S. surgical product director for Alcon.
Robert Niemietz, senior director of marketing of surgical retina for Bausch + Lomb, reports, “Specific to the development of new VR technologies, our working landscape quickly changed. All functions not essential to manufacturing were moved offsite to protect the supply chain. This included the Research & Development group and supporting personnel.”
Some companies even started manufacturing personal protective equipment (PPE) to help address the global shortage. “We understand that the pandemic has led to a critical shortage of PPE. As a result, in addition to our traditional business, we have repurposed and mobilized part of our workforce to start producing robust, reusable and disinfectable face shields to meet the growing need for quality PPE across the world,” said Mythri Pullela, marketing associate from Volk Optical.
Telemedicine becomes crucial
This pandemic has highlighted a need for remote digital monitoring and telemedicine in ophthalmology. Linda Lam, MD, MDA, chief scientific and strategy officer of Ocutrx Vision Technologies, stated, “Ocutrx was initially founded to develop the augmented reality (AR) headset Oculenz to help the founder’s father, who had severe macular degeneration, to see centrally again.” The device was a success, enabling the founder’s father to see well enough to read emails and to see faces again.
“Since the initial Oculenz AR prototype, we have developed both an AR ORLenz headset for digital surgery and the AR Oculenz headset to improve vision and enable in-home monitoring for patients with macular degeneration. Post-pandemic, our company has seen heightened interest from patients, physicians, investors and health-care companies to put the Oculenz device on the market as quickly as possible. We are propelling pace of development of the patient headset Oculenz due to the increased and urgent demand for in-home monitoring.”
In addition, Genentech reports development of a home vision-monitoring technology that is designed to provide longitudinal visual function data gathered from patients outside the clinic.
The COVID-19 pandemic has most certainly shed light on the importance of durability of injectable agents for wet AMD, diabetic eye disease and retinal vein occlusions. The Port Delivery System (PDS) with ranibizumab from Genentech is one technology that could help fill that need, as it has the ability to deliver drug on a continuous basis for prolonged intervals (Figure 1). This technology has the potential to enable a level of certainty in patient outcomes with two administrations a year, compared to the current standard of care anti-VEGF therapies that require more frequent interventions.
Genentech recently announced that the Archway trial met its primary endpoint, demonstrating that patients with PDS who received refills every six months achieved visual acuity outcomes equivalent to those receiving monthly ranibizumab 0.5 mg injections (https://www.gene.com/media/press-releases/14854/2020-05-26/port-delivery-system-with-ranibizumab-sh ).
New technologies impeded
Many companies have noted that a reduction in VR surgeries and tradeshows has resulted in a reduction of revenue and has impacted the ability to trial new devices in the operating room.
“Our internal R&D efforts proceed, but we cannot get access to surgeons in the ORs to try our new developments, so R&D can only take us to the point where we are awaiting critical trials of the product,” said Megan Reynolds, director of marketing for Katalyst Surgical. “That’s where we often discover shortcomings. We continue our R&D efforts, but we fear that ORs will be very slow to reopen to ‘non-essential’ salespeople as we emerge from this pandemic.”
WHAT VR TECHNOLOGIES, IF ANY, DO VR SURGEONS FIND MOST COMPELLING AT PRESENT?
Better, faster, safer
Retina surgeons have long been attracted to technologies that may improve surgical cost, efficiency, outcomes, ergonomics and durability. To that end, our industry partners have been developing a variety of new microsurgical devices and surgical viewing systems.
From B + L’s Mr. Niemietz: “We see a lot of interest in gene therapy and in effect the devices that will enable a consistent and precise delivery of the vector in the right space. Additionally, there is significant interest and need for 27-g instrumentation with increased utility and improved efficiency for the entire platform. We continue to invest in our Bi-Blade dual port vitrectomy cutters and Vitesse Hypersonic technology to meet this growing need.” (Figure 2)
Other companies have also noted a continued interest in high-speed cutters. Per Alcon’s Mr. Lee: “The beveled tip of the Advanced ULTRAVIT Beveled High-Speed cutter provides closer proximity of the port to the retina. Late this year, we will begin shipping the HYPERVIT Dual-Blade vitrectomy probe, which includes all of the benefits of Advanced ULTRAVIT with the addition of 20,000 cpm capability and further improved vitreous flow” (Figure 3).
Ergonomics: The perennial problem
“Given data showing that over half (51%) of ophthalmic surgeons complain of back or musculoskeletal issues due to poor ergonomics of the standard operating microscope, there is compelling need for technology that improves ergonomics and occupational health for the ophthalmic surgeon,” said Ocutrx’s Dr. Lam.
This is one of the driving forces behind the development and interest surrounding the upcoming ORLenz from Ocutrx and 3D heads-up display systems such as the NGENUITY from Alcon and the Zeiss ARTEVO 800 from Zeiss.
HOW HAS THE COVID-19 PANDEMIC AFFECTED THE PRIORITIES OF VR SURGEONS REGARDING VR SURGICAL TECHNOLOGIES?
Expect greater urgency
The companies we interviewed agreed that surgical efficiency and cost-savings will be of even greater importance in the coming months.
“As we get back to doing more non-urgent/non-emergent cases, we believe that surgeons will be looking to maximize efficiency while still delivering great outcomes. We think there will be a high priority on technology that helps achieve those two goals,” Mr. Lee said.
The tools of tomorrow
There does not, however, appear to be a reduction of interest among VR surgeons for continued surgical innovation, even during these unprecedented times. “The pandemic has slowed the volume of current VR surgeries. However, we have not found any diminished interest in our ORLenz technology,” said Ocutrx’s Dr. Lam. “In fact, we have gotten more inquiries given that surgeons have more time to collaborate via medical webinars and in research due to decreased clinical volumes.”
WHAT TECHNOLOGIES DO YOU THINK WILL BE OF PARTICULAR INTEREST TO VR SURGEONS AS THE WORLD EMERGES FROM THIS PANDEMIC AND SURGICAL VOLUMES INCREASE?
Hit the ground running
Given the backlog of elective surgical cases as a result of statewide shutdowns, VR surgeons will likely be inundated with cases as restrictions ease.
Per B + L’s Mr. Niemietz: “Retina procedures will be competing for OR time with everyone else. We could see retina procedures scheduled in the evening or on weekends and a need for additional equipment to open a second or third retina OR in many facilities. We believe the dual-function (phaco/vitrectomy) Stellaris Elite platform uniquely positions us to support this additional capacity.”
With an increase in surgical volume, there will be a greater importance on rapid turnover and minimizing cross-contamination. “Given the current scenario with support staff being limited to perform rapid reprocessing of surgical equipment and the mounting concern around infection, the adoption of single-use surgical lenses has seen a sizeable increase. Single-use VR lenses provide convenience and assurance and come ready to be used in pre-packaged, sterilized Tyvek pouches” per Volk’s Ms. Pullela.
Digitally assisted vitreous surgery offers many technical and ergonomic advantages to surgeons via a 3D head-up display. In the COVID-19 era, the need to use additional PPE may make a heads-up display more comfortable to use. Additionally, not having direct contact with microscope oculars, a potentially contaminated surface, may be appealing. “Technologies that enable the surgeon to be more efficient, to improve visualization and to improve ergonomics in the operating room will be most compelling to vitreoretinal surgeons. With improved ergonomics and efficiency, ORLenz will be an important technological innovation for vitreoretinal surgery,” said Dr. Lam of Ocutrx.
Additionally, Katalyst will release the Awh MVP (Micro Vacuum Pick). The tip of the MVP device incorporates “micropicks” to create an edge of internal limiting membrane (ILM) from which a peel can be initiated, a spatula that can be used to elevate the ILM/epiretinal membrane edge and a small vacuum port connected to active suction. The MVP device can thus initiate and complete a membrane peel using a single instrument. Additionally, the suction of the MVP device can be used to perform a fluid-air exchange. The company says the multifunctionality of the MVP device allows it to eliminate the need for multiple instruments during routine macular surgery, with potential time and cost savings.
WE WILL RECOVER
COVID-19 reminds us of the perils of making predictions, but we think that vitreoretinal surgeons will continue to enjoy the innovation and improvements that have characterized our profession.
While the coming months will doubtless bring new challenges, retinal surgeons are poised to make it through stronger than ever with the help of new and innovative surgical tools in our armamentarium. OM