In 2010, the U.S. Food and Drug Administration (FDA) approved a novel device from Samsara Vision called the Implantable Miniature Telescope (IMT). The device magnifies what a person with late-stage, age-related macular degeneration (AMD) sees in “straight-ahead” central vision. Specifically, the IMT projects an image onto undamaged retina sections, enabling a person to recognize and identify previously unseen objects. Patients may learn to recognize the faces of friends and family and enjoy leisure activities like watching TV or reading.
New Version of the Telescope
As part of the CONCERTO study, a U.S.-based Food and Drug Administration (FDA) study, an evaluation is underway for a new version of the IMT, the investigational Smaller-Incision New- Generation Implantable Miniature Telescope (SING IMT™). The latest version (see picture above) is being evaluated for improvements in safety and visual acuity of the device in people with late-stage AMD. Already approved in Europe, the SING IMT™ design differs from the original device. It can be folded and inserted through a device delivery system that allows for a smaller incision and less complicated surgery.
Potential Candidates
Are you or someone you love a potential candidate for this study? Here’s what to know:
- The study will last about 12-15 months, and the treated eye will be examined in five visits (post-operatively) over 12-15 months with a study care provider.
- Eligible participants must be at least 65 on the pre-operative visit date and have decreased vision associated with late-stage AMD.
- SING IMT™ will be implanted in an outpatient procedure into one eye to improve visual acuity.
- Participants cannot have had previous cataract surgery in the study eye.
- There will be separately scheduled visits (up to 10 over 12 months) with a low-vision occupational therapist who will help train the SING IMT™ recipient on using the new implant.
- The study will occur at sites nationwide and is currently enrolling in California, Florida, Massachusetts, New Jersey, Nebraska, North Carolina, Pennsylvania, and Texas.
Study Participation
Learn more about joining the study or call1-866-393-3767.
Physicians interested in referring late-stage AMD patients to the CONCERTO study, follow the steps below.
- Visit Oraconnects.com/find-a-trial/amd/ for more information and complete the contact information section for a potential patient. A clinical study representative will contact the patient for a pre-screening discussion within 72 hours.
- Call 1-866-393-3767 to speak to a clinical study representative.
- Have the patient/caregiver call 1-866-393-3767 to discuss eligibility and potential participation and answer any questions they may have.
The SING IMT™ is not a cure for late-stage AMD. Moreover, it will not return vision to a patient’s level before AMD, nor will it completely make up for vision loss. The most common risks of the SING IMT™ surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure. Significant adverse events include corneal edema, vision-impairing corneal edema, a decrease in visual acuity and a risk of device dislocation or being in the incorrect position, requiring additional surgery to remove the device.
Additionally, there is a risk that having the telescope implantation surgery could worsen your vision rather than improve it. Individual results may vary.