New Clinical Trial
(posted August 2003)
As part of The Foundation's research and public health mission, we wanted to
share information about an FDA-approved clinical trial of an investigational
device.
VisionCare Ophthalmic Technologies, Inc., is currently enrolling patients for a
phase II/III multi-center clinical trial to test the safety and effectiveness
of the company's Implantable Miniature Telescope (IMT) in patients with
moderate to severe vision loss in both eyes due to dry or resolved wet
(scar-stage wet) age-related macular degeneration (AMD) or Stargardt disease.
The IMT is a tiny telescopic device that is surgically implanted inside one eye
to magnify images over a wide portion of the retina, functioning much like a
telephoto lens of a camera. The IMT is implanted by an ophthalmic surgeon in a
45-minute outpatient procedure. The implanted eye provides central vision,
while the non-implanted eye provides peripheral vision for safe mobility and
navigation. Because the IMT is implanted inside the eye, it is hardly
noticeable to others.
To be considered for the clinical trial, patients must have dry or scar-stage ,
wet AMD, or Stargardt disease in both eyes. Individuals with active wet AMD are
not eligible for this trial. Additionally, patients with recent active wet AMD
must have ended therapy at least six months prior to enrolling in the clinical
trial. Visual acuity must be between 20/80 and 20/800 in both eyes.
By participating in this clinical trial you will be helping to gauge the
effectiveness of this device in helping to enhance central vision. It is
possible that you will experience improvement in central vision, but it is also
possible that you may not experience a benefit.
It is important to understand that the IMT device cannot totally restore
central vision like before your vision loss began. Candidate patients will
first be tested with an external telescope to determine whether they will
likely benefit from the IMT device. After the implant procedure, patients must
participate in vision training sessions to help adapt to the device. Vision
training is an important part of the trial, and candidate patients must be
motivated to participate.
To download the Eligibility Criteria checklist pdf file, which is also the
eligibility form which your doctor must fill out, you must have Adobe Acrobat
Reader. If you do not have Acrobat Reader, you can download a free copy at
http://www.adobe.com/products/acrobat/readstep2.html.
If you are interested in this clinical trial, you must first have your eye
doctor complete the eligibility form, which you can get using the link above.
You will NOT be considered for this clinical trial UNLESS your doctor completes
the form and faxes or mails it to VisionCare.
Because the trial will require participants to attend follow-up sessions over a
two-year period, travel is an important consideration in deciding whether to
participate in this clinical trial. Here for a list of cities with centers
participating in the clinical trial:
Arizona - Tucson
California - Los Altos; Los Angeles; Irvine
Florida - Sarasota
Georgia - Atlanta
Illinios - Chicago
Kentucky - Paducah
Maryland - Rockville
Massachusetts - Boston
Michigan - Ann Arbor; Royal Oak
Minnesota - Stillwater
Missouri - Independence
New Jersey - Lakewood
New York - New York
North Carolina - Charlotte; Raleigh/Durham
Ohio - Beachwood
Oklahoma - Oklahoma City
Oregon - Eugene
Pennsylvania - Philadelphia
Tennessee - Memphis; Nashville; Knoxville
Texas - Houston; San Antonio
Wisconsin - Milwaukee
We also ask that you do not call The Foundation or VisionCare about this
clinical trial, as neither organization can handle the large call volumes this
announcement will generate. Click here for
eligibility criteria and answers to common questions.
The VisionCare IMT device is experimental, and, therefore, The Foundation does
not endorse the device or suggest that this is a better alternative to
traditional low-vision aids that magnify images. The Foundation does not
exclusively endorse nor accept responsibility for this research. We encourage
you to discuss all medical decisions with your doctor.
If you'd like to learn more about the VisionCare clinical trial and the IMT
device, feel free to read the answers to common questions about the trial (link
above), or visit their Web site at
www.visioncareinc.net.
We hope you find this information useful in your healthcare decisions for
macular degeneration and Stargardt disease.
Sincerely,
Board of Directors
Macular Disease Foundation
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