CAUTION — INVESTIGATIONAL DEVICES, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE. THESE PRODUCTS HAVE NOT BEEN APPROVED BY THE FDA AS SAFE OR EFFECTIVE.
The design of the Rheon Medical eyeWatch™ is intriguing. It is made up of a silicon tube with an internal diameter of 0.2mm. One end of this tube is inserted into the anterior chamber allowing fluid to exit the eye and form a bleb at the other end of the tube. What makes this device unique is that the internal diameter of the tube can be adjusted after it has been implanted. In theory this should allow the surgeon to adjust the rate of flow out of the eye in the office after surgery has been completed. If the rate of flow can be adjusted then better control of post-operative intraocular pressure (IOP) should be possible.
The Rheon Medical eyeWatch™ is intended to be implanted under a scleral flap in a manner similar to that used with the EX-PRESS® Glaucoma Filtration Device. As such, all short-term and long-term bleb-related risks would still be present with use of this device. However, the much-feared early post-operative hypotony (IOP that is too low) should be much more easily treated simply by “dialing” the Rheon Medical eyeWatch™ to the appropriate flow setting.
How Well Does the Rheon Medical eyeWatch™Appear to Work?
The Rheon Medical eyeWatch™ has already received the CE mark for use in Europe. Yet there do not appear to be any published human studies demonstrating its safety or benefit. This makes one wonder just what is required to gain “CE mark” status. I readily admit that I consider the FDA to be a bloated, inefficient, and ultimately corrupt agency that hands out approvals to corporations with deep pockets and connections while restraining innovative technologies that threaten established technologies. Nonetheless, the fact that the Rheon Medical eyeWatch™ has gained CE mark status (without publicly available clinical results) gives me new-found respect for the US FDA…well, at least I’ve lost respect for the European CE Mark.
Risks of Implanting the Rheon Medical eyeWatch™
As the Rheon Medical eyeWatch™ is a Glaucoma Drainage Device that also requires maintenance of a bleb to function, it shares many of the risks of both Glaucoma Drainage Devices and Trabeculecomy. In theory, however, the risk of post-operative hypotony should be limited due to the unique flow adjustment feature.
In theory the Rheon Medical eyeWatch™ should allow the surgeon to “dial in” the IOP after implantation. In practice I doubt it will be so straightforward. Nevertheless, I respect the concept as well as the team that no doubt worked very hard to create such a small marvel of mechanical engineering. Is it any wonder that this “watch” is a Swiss creation?
- Villamarin A, Roy S, Bigler S, Stergiopulos N. A new adjustable glaucoma drainage device. Invest Ophthalmol Vis Sci . 2014;55:1848–1852. DOI:10.1167/iovs.13-12626
- Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010;30:661-668.
David Richardson, MD
Medical Director, San Marino Eye
David Richardson, M.D. is recognized as one of the top cataract and glaucoma surgeons in the US and is among an elite group of glaucoma surgeons in the country performing the highly specialized canaloplasty procedure. Morever, Dr. Richardson is one of only a few surgeons in the greater Los Angeles area that performs MicroPulse P3™ "Cyclophotocoagulation" (MP3) glaucoma laser surgery. Dr. Richardson graduated Magna Cum Laude from the University of Southern California and earned his Medical Degree from Harvard Medical School. He completed his ophthalmology residency at the LAC+USC Medical Center/ Doheny Eye Institute. Dr. Richardson is also an Ambassador of Glaucoma Research Foundation.