Patient Center
Resources for Patients with AMD |
 |
Frequently Asked Questions
This page is designed to answer common questions about AMD, the Implantable Miniature Telescope IMT (by Dr. Isaac Lipshitz), and the clinical research trial designed to study this medical device for use in age-related macular degeneration (commonly called AMD).
Please understand that this medical device is not a cure for macular degeneration. It is a tiny telescopic device that is surgically implanted in one eye to magnify images on the light sensing cells of the retina. The telescope implant, which is currently undergoing clinical investigation, is intended to improve central vision in the implanted eye and quality of life.
About AMD and the telescope implant
What is AMD (age-related macular degeneration)?
AMD is a condition of the eye that affects the central retina, or macula, located in the back of the eye. There are two forms of AMD that cause the macula to degenerate, leading to various levels of vision loss. The 'wet' form of the disease can cause fluid and blood to leak onto the macula. In the 'dry' form of the disease, the macula breaks down without any leakage of fluid. Both forms can lead to end-stage AMD in which there is significant permanent central vision loss.
How does AMD affect vision?
The macula is important to eyesight since it is the part of the eye responsible for detailed central or "straight ahead" vision. Although people with AMD rarely go completely blind because of this condition, they may find it difficult to read, recognize faces or colors, drive, and perform other daily functions that require central vision.
What is the (IMT by Dr. Isaac Lipshitz)? How can it help people with AMD?
I-M-T stands for Implantable-Miniature-Telescope. It is a tiny telescopic device that is placed inside the eye by an eye surgeon. The implant functions like a telephoto lens of a camera. Once implanted inside the eye, it magnifies images onto the retina to help improve vision.
What form of AMD can the telescope implant help?
The implant is being evaluated for patients who have a scarred macula (end-stage AMD) in both eyes due to either the wet or dry form of AMD. Your ophthalmologist can tell you if you have end-stage AMD.
What does the telescope look like in the eye? Can others see it?
The telescope is virtually unnoticeable to others because it is implanted totally inside the eye, and mostly covered by the colored portion of the eye (iris).
Are there other treatments available?
Unfortunately, there currently are no treatments available for patients with end-stage AMD. External telescopes worn outside the eye are used by some patients with end-stage AMD in an attempt to improve vision. VisionCare's investigational telescope implant is currently being evaluated in a clinical trial to determine whether it may help patients with end-stage AMD see better and improve their quality of life.
Frequently Asked Questions about the Clinical Research Trial
What is a clinical trial?
A clinical trial is a study to test the safety and effectiveness of a new drug or medical device in patients. A physician supervises the research and follows a clinical protocol, or study plan. Studies of new medical devices or new drugs also require approval of the U.S. Food and Drug Administration (F.D.A.).
Why is the IMT-002 clinical trial being conducted?
The trial is being conducted to evaluate the safety and effectiveness of the telescope implant. Patients will be observed for changes in vision and side effects. Data will be tabulated and submitted for product approval.
Have any other patients been treated with this implant?
A limited number of patients have been implanted with the device in early clinical trials to evaluate the safety and effectiveness of the device in patients with end-stage AMD. Clinical results have been reported to the F.D.A. to support conducting the initiation of this larger trial of approximately 200 patients.
Who can participate?
Patient enrollment is now complete. Applications for this trial are no longer being accepted. Please visit Clinical Trials for more information.
|