First, there was Intuitive Surgical’s da Vinci robotic system for gynecological, urological, head and neck, and other surgeries. Then came Stryker’s Mako and Smith and Nephew’s Navio robotic systems for joint replacement surgery. Robotic systems such as Intuitive’s Ion
and Monarch by Auris Health soon followed for lung biopsies and other procedures.
Now, as the global population ages, a handful of medical technology companies are investing in the development of robotic systems for cataract surgery. Their goal: to take the procedure to greater levels of precision, safety, outcomes and patient access. It’s a goal that some believe may be achievable within the next decade, if not sooner.
“There’s no question robotic technology will be revolutionizing the way we do eye surgery within the next 10 years,” says Jean-Pierre Hubschman, MD, co-founder and CEO of Horizon Surgical Systems. “Cataract will be the first application, as it is a high-volume surgery and highly repetitive, so it’s perfect for robotic technology. It will then most likely disrupt all of [ocular surgery] by bringing higher safety and efficiency to patients and surgeons.”
Joseph Nathan, MD, MSc, founder, president and chief medical officer of ForSight Robotics, makes an even more optimistic forecast. “Robotics is not something that will happen in 10 years,” he says. “It’s something that will happen in a few years.”
Precision, accuracy, consistency
Perhaps the greatest potential of robotic technology lies in improving the precision, accuracy and consistency of cataract surgery. Robotic systems promise sub-millimeter accuracy, offering a level of precision that cannot be achieved manually. By eliminating the hand tremor associated with manual procedures, the system could reduce the likelihood of complications and provide patients with a more reliable experience.
“We can get to 10, 20 microns of accuracy, whereas the human hand accuracy is around 150 microns, so [robotics] is 10 times more precise and accurate,” says Dr. Nathan.
ForSight, a startup based in Yokneam, Israel, is developing a platform called ORYOM — Hebrew for “daylight” — a combination of miniature mechanics, advanced visualization and cognitive AI-based algorithms that provide surgeons with real-time guidance.
“The surgeon controls the robotic system and sees a real-time, 3D augmented surgical view that helps guide the procedure,” Dr. Nathan explains. “This is an end-to-end platform. You don’t need to lean towards the microscope. Our visualization technology is coupled with the hardware and software within the robotic platform.”
Meanwhile, spun off from the University of California Los Angeles, Malibu, Calif.-based Horizon Surgical Systems is developing a platform that combines visualization systems, machine learning and micro-precision arms to provide surgeons with augmented feedback and enhanced precision.
“It will enable the surgeon to perform a better job, because the system will bring an unmatched detection of the ocular anatomical structures. For instance, the surgeon will be able to properly visualize the posterior capsule, which is barely visible through a normal optical or digital microscope,” Dr. Hubschman explains. “All the safe boundaries of the surgical workspace will be identified more precisely and accurately.”
The precision and predictability offered by robotic-assisted systems are expected to significantly reduce the risk of intra- and postoperative complications, according to Dr. Nathan. “Today, if you make a wrong movement, the patient suffers. But with robotics, you can have no-fly zones, meaning that even if the surgeon accidentally makes a particular movement, the robot doesn’t follow. There are a lot of things that all play together to make sure the consistency and the level of care are really superior to what the human surgeons can do. Robotics are an intuitive addition to the operating room.”
Less pain and fatigue
Cataract surgery can be physically demanding, as it often involves spending several hours a day operating on patient after patient. Robotic systems promise to help reduce the chronic pain and fatigue experienced by surgeons. Horizon’s surgical robotic platform, for example, will assist the surgeon for all surgical steps, allowing to reduce the fatigue normally experienced after a long surgery day.
“Sixty-six percent of ophthalmologists say ergonomics is a big health issue in terms of head and neck related health conditions, and 14% plan to terminate their career early due to ergonomics-related issues,” Dr. Nathan says.
By leveraging heads-up, 3D technology and other aspects of the robotic platform, robotics could eliminate much of the discomfort that comes with performing cataract surgery, he says.
Enhancing access to surgical care and training
According to the World Health Organization, at least 2.2 billion people worldwide have near or distance vision impairments, most which are caused by refractive errors and cataracts. However, of those with cataracts, only a fraction (about 17%) have access to treatments that can restore their vision.
Moreover, iOR Partners, a developer of office-based ophthalmic surgery suites, estimates that some 10 million cataract surgeries a year will be performed in the United States and more than 60 million worldwide within the next 25 years, owing to the aging population and increased life expectancy.
The supply of ophthalmic surgeons, however, is shrinking. According to a 2016 report by the U.S. Department of Health and Human Services (HHS), by 2025 the country will have 16,510 ophthalmology surgeons, some 6,000 short of the 22,690 surgeons the HHS says will be needed to meet demand for cataract and other ocular surgeries. By its potential to increase patient throughput and to be employed remotely, robotics could address patient demand while also mitigating the shortage of surgeons.
“There is more and more cataract surgery to perform every year, but fewer surgeons are getting trained in the United States and even more so outside the United States. This technology will help democratize superior care to everyone,” Dr. Hubschman says.
Robotics could also enable experienced surgeons to train less-experienced peers remotely in the United States and around the world in less time and without having to travel. This could be especially helpful in areas such as the Middle East, China and Africa that lack high-quality surgical training programs.
“We know that a good cataract surgeon takes 15, 20 years to train. They go to medical school, residency, fellowship and then take 5 to 7 years just to get a good understanding of the procedure. But you don’t really know how well you are doing or how to improve yourself without interacting with other surgeons and physically going there,” Dr. Nathan says. “This is really a game changer in the way that surgeons can acquire expertise.”
Built to assist, not take over
Much like Intuitive Surgical’s da Vinci and Stryker’s Mako systems, both doctors interviewed emphasize that robotics will always remain an assistive technology in ocular surgery — one that will never fully take the place of human surgeons.
However, they agree its level of autonomy will gradually increase over time. Dr. Hubschman draws a comparison to the evolution of autonomous cars. On a scale of zero to five, a fully autonomous vehicle, without the need for a steering wheel or a human driver, would be at level five. The current “self-driving” vehicle that requires a human driver but can change lanes, brake and accelerate on its own, on the other hand, corresponds to a level two of autonomy.
“You need to go step by step to build confidence [in users], because even though the technology is here to provide more assistance, I don’t think you would buy a car with no steering wheel at this stage,” Dr. Hubschman says. “It’s exactly the same with robotics in cataract surgery. We’ll go step by step to build confidence of the FDA, the surgeons, and the patients.”
He believes, however, the potential is there to eventually reach “level five,” with just one technician, one robotic system and one surgeon in the room to take over in the event of an emergency.
“The initial level of autonomy will need the surgeon to sit at the surgical cockpit, actively supervising and validating every surgical step proposed by the system,” he says, likening that degree of surgeon involvement to “level two.”
For now, robotic-assisted cataract surgery remains a work-in-progress. Still, its potential to transform cataract surgery — and other ocular surgeries, for that matter— into a safer, more accessible, and more predictable procedure for millions of people worldwide is clear in the eyes of those working at the leading edge.
The combination of artificial intelligence with robotics has tremendous potential to improve surgeons’ performance and deliver better outcomes to patients.
“It’s really a revolution that is coming,” Dr. Nathan says. OM