VisionCare IMT Clinical Trial Eligibility
Criteria and Common Questions
General Criteria - Please note: the eligibility form must be filled out by
your eye doctor to be considered for participation.
Patients must be 55 years of age or older and have:
- Stable, untreatable macular degeneration (AMD or Stargardt disease)
- No evidence of active wet AMD or treatment of wet AMD within the last 6
months
- No previous history of intraocular, corneal, or refractive surgery in
the eye to be implanted
- No other eye disease except for well-controlled glaucoma or cataract
- Visual acuity no better than 20/80 or worse than 20/800 in both eyes
- Good peripheral vision
- Be available and committed to attend preoperative visits, 9 medical
follow-up visits, and 6 vision training sessions for 2 years after the
procedure
Common Questions
Q: What if I've had cataract surgery before?
A: Patients who previously had cataract surgery in one eye may be eligible for
the trial, as the other eye can still be implanted. However, patients who have
had cataract surgery in both eyes are not eligible for this clinical trial.
Q: Can I participate if I am younger than 55?
A: Patients must be 55 years or older to participate in this trial as per the
protocol requirements.
Q: What if I meet all the criteria except for age or cataract?
A: If you meet all the criteria other than those for age or previous cataract
surgery, you can still send in the form if you would like to be notified if the
criteria change in the future.
Q: If I have impaired central vision in only one eye or vision disorders
other than those described in the eligibility criteria, can I be considered for
participation in this clinical trial?
A: No. At this time, the Implantable Miniature Telescope (IMT by Dr. Isaac
Lipshitz) is being clinically evaluated only in patients who are 55 years of
age and older with dry or resolved (scar-stage) wet AMD or Stargardt disease.
Q: How is the IMT different from other devices for central vision loss?
A: The IMT differs from other devices because it is implanted inside the eye.
With the IMT implanted in the eye, an individual can scan reading materials and
images using natural eye movements. The IMT is designed to provide a large
field of view and does not require the use of any bulky external devices or
headgear. Normal reading and distance glasses are prescribed after the
procedure for near and far activities.
Q: If I volunteer, will I see like I did before my macular degeneration
began?
A: Please understand that the IMT is not a cure for macular degeneration, but a
tiny telescopic device that magnifies images inside the eye. Your vision may or
may not improve. Patients considering participation should understand that the
device may help improve your central vision to some degree to help with
activities like watching TV, reading, and recognizing people, but not like
before your central vision loss began. Patients who appear eligible will be
tested with external telescopes before being enrolled in the study to see if
their vision improves on an eye chart.
Q: Is there any cost to participate?
A: Study related expenses for individuals participating in the trial are
covered by the study sponsor. Travel to and from the clinical center conducting
the trial is the responsibility of the patient.
Q: What happens if I am found to be a candidate after sending in the form?
A: After the form is reviewed and it is determined that you may be a candidate
for participation in the study, it will be forwarded to the investigational
center closest to where you live. You will be contacted to set up an
appointment for an examination and to be tested with external telescopes. This
process may take several weeks. At the trial center, you will be informed of
the known and potential risks of implantation of the IMT device and potential
benefits of participation in the clinical trial.
| 