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Frequently Asked Questions About AMD, the MacuScope™, and Testing Procedures
Is the MacuScope™ registered with the FDA and built to standards set by the FDA?
Yes. The Macuscope™ is registered with the FDA as a class 1 exempt device and is manufactured in an FDA-approved facility to standards set by the FDA. There are currently no other medical instruments that measure macular protective pigment density that can make these claims. The MacuScope™ will meet comparable medical and safety guidelines world-wide by years end.
Why is it important to be classified as an FDA registered device?
The Macuscope™, as a registered device meets or exceeds federal medical and safety standards and qualifies as a medical instrument which can be utilized for reimbursement of medical procedures in the United States. Instruments that are not approved and/or not manufactured to such standards may not qualify for reimbursement, and in fact, could be subject to re-coupment as a result of medical insurance companies' scrutiny.
Has the MacuScope™ been validated against other instruments and other methods of determining macular protective pigment density?
Yes. According to the top researchers in the world, heterochromatic flicker photometry, Now The MacuScope™ is widely regarded as the standard against which other methods of measuring macular protective pigment density are judged and validated. The MacuScope™ has been validated in the research laboratories by reproducing the same protective pigment densities as other research companions. The MacuScope™ is the incarnate of the laboratory instrument.
Why does the MacuScope™ utilize a narrow band efficiency filter, as apposed to an LED light source?
The MacuScope's™ technology is superior to devices that use LED's as test light sources. The MacuScope™ employs a narrow band interference filter that defines a specific test wavelength so that no correction factor is necessary. LED's are broadband width, and measure some type of non specific optical density over the LED's wide wavelength range. This greatly decreases the accuracy. Also, the lower luminance produced with an LED light source compromises the integrity of the test.
Does AMD cause blindness?
Yes. AMD is the leading cause of legal blindness in the world.
How can periodic testing by the MacuScope™ help to combat AMD?
The macula is the part of the eye that you aim with when you look at something. It is responsible for critical vision tasks like driving and reading. The MacuScope measures the macular protective pigment density (MPPD) of the macula. Research has shown that decreased MPPD is one of the major contributors to AMD. If a patient is determined to have a low MPPD, the doctor can recommend a treatment program of ocular supplements, which can re-pigment the macula.
How long does the test take, and is it painful?
The test is painless, non-invasive, takes about 3 minutes, and does not require dilation.
Does a patient need to be dilated for the exam?
No. No dilation is required.
Should a patient have both eyes tested?
No. Over 20 years of research has shown no statistical validation for the need to test both eyes. What you measure in one eye is nearly what you have in the other.
Does the MacuScope™ make the diagnosis of AMD?
No. The MacuScope measures the MPPD of the macula and places patients into a high or low risk category for developing AMD. Low MPPD can precede the onset of AMD by decades!
Since AMD is generally a disease of people over 55 years old, should patients wait until they approach that age to be tested?
No. The MacuScope has detected low MPPD in much younger people. A baseline should be determined for everyone over age 21 and especially patients with a family history of AMD, or other risk factors. Since damage to the delicate retina is cumulative and permanent, the younger a person can achieve and maintain a normal MPPD, the less risk they have of getting AMD. The objective is to give patients decades of protection.
Does a prior family history of AMD affect when people should be tested?
Yes. There is a strong genetic link for AMD and all family members should be tested.
What are the risk factors for AMD?
- Low MPPD
- Age
- Family history
- Gender - Women at greater risk
- Smoking
- Obesity
- Sun exposure
- Fatty diets/Poor nutrition
- Light colored eyes
- High blood pressure
- Cardiovascular disease
- Certain medications
- Farsightedness
- High myopia
- Early menopause
How often should a person be tested?
Every 1 to 2 years in conjunction with a normal eye exam. Those with a low MPPD may need testing at 6 month intervals to monitor supplement therapy.
If I am currently taking an ocular supplement, do I still need to be tested?
Yes. There are many ocular supplements available and ingredients vary greatly. It is important to determine the supplement's effectiveness in re-pigmenting the macula. There are three carotenoids that make up the MPPD; lutein, meso-zeaxanthin, and zeaxanthin. It is recommended that all three of these be present and taken in appropriate amounts daily. The MacuScope™ can measure and monitor the effectiveness of supplement therapy.
What is the goal of the MacuScope™?
To pro-actively prevent the expected epidemic growth of blindness caused by AMD.
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