March 2015




Implantable Miniature Telescope: FDA-approved for end-stage AMD

by EyeWorld Staff

Implantable Miniature Telescope

Implantable Telescope

eye telescope

The Implantable Miniature Telescope

The Implantable Miniature Telescope Source: VisionCare

The Implantable Miniature Telescope (VisionCare, Saratoga, Calif.) is implanted monocularly to improve vision in patients who are 65 years of age or older and who have stable severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) that is caused by bilateral central scotomas associated with end-stage age-related macular degeneration (AMD). It is the only Food and Drug Administration-approved surgical device for end-stage AMD. The telescope, which is smaller than a pea, can be implanted in one eye during an outpatient procedure. It renders enlarged central vision images over a wide area of the retina to improve central vision. The non-operated eye provides peripheral vision for mobility and orientation.

We have new treatments for macular degeneration that are highly effective, but unfortunately, for geographic atrophy, we dont currently have any effective treatments, and vitamins are not as effective as we would like them to be, said David Boyer, MD, clinical professor of ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles.

Patient selection

According to Sumit Sam Garg, MD, interim chair of clinical ophthalmology and medical director, Gavin Herbert Eye Institute, University of California, Irvine, ophthalmologists should be excited about this device because it provides a new alternative for patients with end-stage macular degeneration. These are some of our most challenging patients, he said. They are people who have bilateral central vision loss. Often, they are depressed and lose their independence. With this procedure, the telescope is implanted in one eye in a patient who has not had cataract surgery. The goal is to improve his or her vision and gain some independence back. That gives the patient a better outlook on life and lets him or her get back to what he or she enjoys doing. One of my patients enjoyed watching baseball, and over several years, he became unable to watch it. After implanting the telescope, he was able to watch his Angels play, and that brought so much joy to him, Dr. Garg said.

According to Dr. Boyer, patients with end-stage AMD should undergo a complete evaluation by a low-vision specialist who is familiar with this procedure. Patients should be tried on external devices, and they should be given a simulator to determine what they would be able to see if the telescope was inserted. Once it is inserted, patients need to return to the low-vision specialist to help the brain adapt to this new technology. If they are motivated and want to do this, they will be a successful patient, he said.

However, Dr. Boyer cautioned that the device is not for everyone. In order to adapt to the telescope, you are using one eye to get around and navigate, and the other eye is only used for peripheral vision. A patient cannot expect to be able to drive with this device, but fortunately, you only lose about 15% of your peripheral vision by using one eye, he said.

Dr. Garg agreed that the telescope is not for all end-stage AMD patients. They have to be willing to undergo the process that goes along with this. There is a process beforehand to make sure that putting the implant in will improve vision, he said. Patients should be warned that the visual improvement can take some time, and they will need to work with the low-vision therapist to adapt to using the telescope. They will still follow-up with their retinal specialist, who follows the macular degeneration and injects if necessary. Prior to implantation, these patients have to be dry macular degeneration patients or quiet wet macular degeneration patients, which means no exudations for 6 months, Dr. Garg explained.

He noted that the telescope was initially approved for patients who are 75 or older, but can now be implanted in patients a decade younger as well. Studies have shown that younger patients actually do better with the telescope than older patients, and I think it makes sense. Their brains may be a little bit more plastic, and maybe their macular degeneration is not as bad. We have patients who go from 20/200 vision to 20/80. That is a huge improvement for them, he said.

Whats new?

As of January 1, the Centers for Medicare and Medicaid Services (CMS) will reimburse the Implantable Miniature Telescope under a revised Ambulatory Payment Classification designation, APC 0351, Level V Intraocular Procedures. This new designation will increase overall reimbursement, and ambulatory surgery centers payment levels will be comparable to those paid to hospital outpatient departments. Before this year, the outpatient surgical procedure for telescope implantation was restricted to hospitals due to reimbursement rules, despite the fact that approximately 80% of ophthalmic surgical procedures are performed in local ambulatory surgery centers. This ruling will enable the broad adoption of therapy by ambulatory surgery centers, which will significantly improve patient access.

Editors note: Drs. Boyer and Garg have financial interests with VisionCare.

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