MACULAR DEGENERATION: (FREQUENTLY ASKED QUESTIONS)

1. WHAT IS AMD (AGE-RELATED MACULAR DEGENERATION)?  

Macular degeneration is a degradation of the macula, which is the central region of the retina that enables people to see in small detail. AMD can degrade this "fine" vision, as well as color vision, contrast/depth of field of vision, and also cause distortion in the form of away field of vision. 

 

One of the primary causes of AMD is an impairment in blood circulation to the retina.  Poor blood circulation can also cause a loss of the retinal pigment epithelium (RPE) cells which assist the photo-light-sensitive rod and cone cells. These rod and cone cells photochemically convert light into an electric signal, which is sent to the brain. This is how light is processed into vision by the brain, enabling sight. Over time, damage from AMD will result in a consistent reduction in vision. At first, AMD will likely negatively affect the ability to read small print or in see well in low light. As this disease continues into the intermediate and advanced stages,  a person's vision will significantly degrade, which can destroy their ability to do even basic things like read, see color, recognize faces, drive, play golf, dress themselves, put on make-up.  Over the duration of the disease,  a patient may lose partial vision, or in some cases experience a complete loss of central vision.

2. HOW MANY PEOPLE ARE AFFLICTED WITH MACULAR DEGENERATION?

Age-related Macular Degeneration (AMD) affects more than 110 million people worldwide (2013); by 2050, per the British Journal of Ophthalmology,  this figure is expected to double to 196 Million people. AMD is a common visual disease that is primarily associated with age.  

 

3. WHAT IS THE TREATMENT FOR MACULAR DEGENERATION?

To date, there have been no cleared (via FDA) drug or device treatments for Dry AMD, and there are no treatments on the market in the US, to improve lost vision for patients with dry macular degeneration. 

 

Wet AMD, the more advanced form of macular degeneration, has several approved therapies.

This includes laser therapy and injections into the eye of Anti-VEGF chemicals, (anti-cancer drugs). The VEGF drugs destroy the growth of new weakened blood vessels,in the retina to compensate for the original atrophied choroidal vessels that caused dry AMD. These new blood vessels are prone to bleeding, and can bleed into the retina, causing wet AMD, on top of the already degraded vision from dry AMD. These drug injection treatments are costly (as much as $2,000 per injection), and often need to be repeated every month to every several months.

 

4. IF I HAVE DRY MACULAR DEGENERATION, WHAT CAN BE DONE NOW?

Currently, some ophthalmologists recommend that their patients regularly take antioxidants, because in some studies, nutritional supplements have been shown, to assist in slowing AMD. (Other studies have failed to confirm this.) 

 

5. HOW DOES i-LUMEN WORK?

i-LUMEN™, with its Neural Retinal Therapy™, creates an electric field using pulsed micro-current stimulation in a proprietary algorithm, specifically placed around the closed eyelid. When the i-LUMEN device is functioning and treatment is applied around the eye, this electric field creates a charged ion stream that gently penetrates the skin, muscle tissue, and wall of the eye, and is projected through and around the eye, to restore blood flow to compromised blood vessels in the retina. This increase in blood flow is accompanied by an increase in cellular membrane permeability, both of which help to restore macular function, by aiding in the restoration of more normal circulation to the retinal photoreceptors, the rod and cone cells, and the support cells and neural components of the retina.   Better blood flow to the retina allows the dying, poorly functioning retinal cells to regain normal function.

 

6. WHAT IS THE TREATMENT REGIMEN FOR i-LUMEN? HOW LONG WILL IT TAKE?

The i-LUMEN™ treatment starts with two sessions a day, over a five day period. This promotes healing of blood circulation within the eye to improve impaired vision. 

 

Patients will need to continue the treatment regimen and will return to the clinic every 3-4 months for a one day re-treatment session to retain the vision gains made in the five day initial therapy, and to low the progression of AMD-related symptoms. 

 

7. WILL THE i-LUMEN™ THERAPY BE PAINFUL?

No. During the i-Lumen™ treatment, patients may experience temporary discomfort, but each treatment is customized to the patient at that time.   

 

8. HOW CAN I MINIMIZE MY CHANCES OF GETTING AMD?

You cannot change your genetics (i.e. heritage, race, skin and eye color). And, genetics is believed to be one of the biggest factors in contracting AMD. But a lifestyle can play a role in reducing your risk of developing AMD. So ideally you should work on staying healthy and doing the following both for general health and for eye health:

  • Do NOT smoke.

  • Do NOT Drink excessively

  • Wear Sunglasses Outside - ALWAYS

  • Eat a healthy diet: low sugar, green vegetables, low fat: poultry and fish.

  • Keep your weight under control and in the normal range.

  • Keep your Blood Pressure in the normal range.

  • Exercise regularly (4x a week +)

 

9. WHERE AND HOW IS AMD DETECTED?

Your eye care doctor is the one who should be regularly checking you for signs of AMD. They have a set of sophisticated tests that can be used in addition to visual inspection to determine if you are starting to show signs of AMD.  Your eye doctor should check you for AMD if you are age 60+ and have recently seen some changes in your central vision. 

The AMD comprehensive eye exam will likely include the following:

  • A Visual Acuity test. An eye chart test to determine how well you see at various distances.

  • Dilated eye exam. Drops are placed in your eyes to dilate, the pupils. Your eye doctor examines your retina and optic nerve for signs of AMD and other eye problems. 

  • Tonometry. This instrument measures the pressure inside the eye. Numbing drops may be applied to your eye for this test.

  • Amsler grid test. The grid pattern is like a checkerboard. Each eye is tested individually. While staring at the dot in the center, some of the straight lines in the pattern may look wavy. This could be a sign of AMD.

10. HOW IS WET AMD TREATED?

Wet AMD is typically treated with injections to the eye; other treatments include:  laser surgery, and photodynamic therapy. None of these treatments will cure wet AMD. They merely treat the symptoms. The disease and loss of vision will likely progress despite these treatments.

 

11. WHAT IS THE CURRENT TREATMENT FOR AMD?  

Patients diagnosed with dry AMD are usually told there is nothing that can be done for them. This is because there have been no market cleared treatments to restore and improve vision for patients with dry AMD.  i-Lumen Scientific anticipates being  first with a market cleared treatment, that has been clinically demonstrated to restore eyesight in patients with AMD. 

 

The National Eye Institute’s Age-Related Eye Disease Study (AREDS) found that taking a specific high-dose formulation of antioxidants and zinc could reduce the risk of advanced AMD and its associated vision loss in a small group of people. This study has been questioned and its findings have been disputed. However, if true, slowing AMD’s progression from the intermediate stage to the advanced stage could temporarily save vision for some people for an undetermined period of time.

 

12. IS i-LUMEN™ AVAILABLE AND WHERE?

The i-LUMEN™ technology and therapy is being planned for initial introduction in the US and Europe. It is not yet available within these markets. 

13. WILL THE  i-LUMEN™ THERAPY INTERACT WITH MY DRUG THERAPIES?

There are no drugs in the i-LUMEN process to interfere with the other drug therapies you may be taking. Your doctor will decide what is best for your personal care.

14. IS AMD CONFINED TO OLDER PEOPLE?

No, there are also several types of juvenile macular degeneration. The most typical form is called "Stargardt's Disease".  Thus, a regular eye exam is important for everyone of all ages.

 

15. WHERE CAN I LEARN MORE ABOUT AMD?

Check with the American Macular Degeneration Foundation, Mac.org,  the National Eye Institute, or the National Institute of Health (NIH)

 

© 2019 by i-LUMEN SCIENTIFIC, Inc.™