Robot Ushers in a New Era of High-Precision Surgery

In the midst of its 200th anniversary, New York Eye and Ear Infirmary of Mount Sinai (NYEE) is welcoming the first robotic system for ophthalmic surgery in the U.S., and only the third in the world. Does that mean mechanical robots may soon be replacing experienced surgeons in the operating room for procedures involving the retina, cornea, cataracts and glaucoma?

“We often get that question, but that’s not how the robot works,” explains Sean Ianchulev, MD, MPH, Professor Ophthalmology at the Icahn School of Medicine at Mount Sinai whose work over the past six years (along with a grant from the RICBAC Foundation to the two principal investigators, Dr. Ianchulev and Joseph Panarelli, MD) that paved the way for the arrival in July of the micro-interventional robot from the Netherlands, home of the device’s creator. “The surgery is really robot-assisted, which means the device serves as an extension of the surgeon’s hand. It translates movement to instrumentation with a level of precision that will allow us to do things we never could before.”

Examples abound. “The robotic assistant could allow surgeons for the first time to enter the subretinal space to deliver stem cells with the potential to treat blindness. It could also open the door to a new era of gene therapy, more advanced corneal refractive and cataract procedures, micro-interventional glaucoma surgery, and retinal vessel cannulation,” explains Richard Rosen, MD, Chief of Retina at Mount Sinai Health System and Director of Ophthalmic Research at NYEE. “As we continue to interact with the device, new questions and ideas come up. So it may take us years to really understand what this technology is able to accomplish. There is no limit to the applications.”

The key to unlocking this vast potential is the ongoing partnership between clinicians at NYEE and engineers from Preceyes BV, the Dutch medical robotics company that developed the device. And as this team prepares for clinical trials required by the U.S. Food and Drug Administration (FDA) for the robot’s usage in this country, members are increasingly aware of its extraordinary powers. Indeed, the first trial set to begin next year will involve retinal surgery, in which micron-level demands on hand movement push even the most skilled practitioners to their physical limits. The robot has the ability reduce the normal 100-micron tremor in their hands to below five microns. “Think of what that 20 orders of magnitude improvement can mean for existing surgeries,” notes Dr. Ianchulev, “or for the creation of new procedures.”

The micro-interventional robot has already been approved in Europe for epiretinal membrane peeling, the first procedure for which NYEE expects to deploy the device following its FDA approval. This delicate surgery removes the micron-thin sheet of cells that grow over the macula, distorting its surface and greatly reducing central vision in many common retinal diseases. Work is also underway to prepare the robot for micro-interventional glaucoma surgery, with plans to add instrumentation that would marry the robot to intraoperative OCT, potentially giving the machine a set of “eyes” so it can navigate within a three-dimensional space.

For now, though, the robotic assistant is leaving its mark in another way. It has been integrated with the EyeSi virtual surgical simulator in the Jorge N. Buxton Microsurgical Center at NYEE’s downtown campus for training surgeons in a safe environment prior to taking their newfound skills to patients. This makes NYEE the only educational site in the world linking surgical robotics to a virtual simulator. That capability could be extended at some point to NYEE’s residency program, giving ophthalmologist- in-training an experience available nowhere else in the country.

For good reason, the new on-site robot is allowing clinicians to think big. The high precision surgical tool is envisioned as a pillar of a new national center of microsurgical excellence in ophthalmology at NYEE. “Robotics, together with telemedicine and artificial intelligence, are the three channels by which we intend to play a leadership role in ophthalmology,” asserts Dr. Ianchulev, who is Director of the Ophthalmic Innovation and Technology Program at NYEE. “We know what’s important to clinical practice today and going forward, and believe the priorities we’ve chosen will get us to both of those destinations while delivering the best outcomes for our patients.”