Nutritional Supplementation, Electrical Stimulation And Age Related Macular Degeneration Leland D. Michael, O.D. and Merrill J. Allen. O.D.,. Ph.D.

Abstract
This is a preliminary report of an ongoing study of the rate of development of age related macular degeneration in people using nutritional supplements and treated with weak electrical currents. Twenty-five subjects, ages 48 to 79 years have been treated for periods from two to seven years. Fifteen subjects have improved their acuity. 10 have lost acuity. Two have had laser treatment, two had to stop because of age and transportation problems and two have died. The subjects have lost an average of 0.30 letters of acuity over an average of 4.0 years. By comparison, Newsome's2 test group lost 4.1 letters and his placebo group lost 7.1 letters of acuity in 2 years using nutritional supplements without electrical treatment. It appears that electrical stimulation of the eyelids can enhance the success rate of nutrients alone in controlling AMD.

Keywords
Age–related macular degeneration, nutrition, zinc, electrical stimulation, micro ampere
Introduction

Age-related macular degeneration (AMD) and cataract are the major causes of visual impairment and blindness in the United States in persons over 55 years of age.1 AMD damages the retinal tissues in the macular area causing fine pigmentary stippling, pigment epithelium changes and the development of drusen. Drusen usually occur in a mirror pattern in both eyes AMD is called “dry” or “wet”. The dry type is characterized with either normal acuity or only a moderate acuity loss, while the wet type may progress to rapid and severe vision loss. The average rate of acuity reduction has not been clearly defined in the literature. At the present time there is no recognized therapy for the dry type of AMD. A study by Newsome et al2 showed that a slower progression of AMD occurred over a two year period, for subjects receiving vitamin and mineral supplements high in zinc compared to unsupplemented (control) subjects. The treatment for the “wet” type of AMD involves using a laser to seal off the leakage in the choriocapillaris layer up through Bruch's membrane. There is the real possibility of further vision loss due to leakage in the area around where the laser burn was applied. This stage of AMD is a depressing time for the patient. In 1983, one of us (LDM) upon recovering from retinal detachment, decided to try to help patients with early signs of macular degeneration. He began a study of the effects of nutritional supplements and micro ampere electrical treatments on the rate of progress of the “dry” type of AMD. Electrical treatment was incorporated because the eye has a electrical potential that may play a role in retinal health and that can be modified with an external source of electricity. (The first patient, age 74 has been in the study for seven years and has had no further acuity decline.)

Procedure
Each patient who was diagnosed as having AMD was referred to a local ophthalmologist who confirmed the diagnosis. The patient was then offered three alternatives; a) evaluation every 6 months; b) use a nutritional supplement and be evaluated every 6 months; or c) use a nutritional supplement and receive micro ampere electrical treatments at least once every month. Most AMD patients chose alternative c) and became part of this study. The control for this study is the data presented by Newsome2 because this study differs from Newsome's study only by the addition of electrical treatment to the area around the eyes.

Figure 1. The formula for the nutritional supplement that we provided to all subjects.
Eight Tablets Contain %RDA
Vitamin A (Fish Liver Oil) 25,000 IU 500
D (Fish Liver Oil) 800 IU 200
Vitamin E (d-alpha Tocopherol Acetate) 400 IU 1336
Vitamin C (Ascorbic Acid) 2,000 mg 333
Vitamin B1 (Thiamin HCL) 100 mg 6567
Vitamin B2 (Riboflavin) 150 mg 8838
Niacin 80 mg 400
Vitamin B6 (Pyridoxine) 150 mg 7500
Pantothenic Acid (dCalcium Pantothenate) 100 mg 550
Inositol 150 mg *
Calcium (Phosphate) 500 mg 50
Magnesium (Oxide) 250 mg 62
Selenium 100 meg *
Zinc (Gluconate) 75 mg 495
Bioflavinoids 300 mg *
Glycine 200 mg *
L-Glutamine 200 mg *
L-Arginine 300 mg *
L-Cysteine HCI 400 mg *
Glutahione 40 mg *

* RDA has not been established. + Vision-Eze Professional Products. 925 Hale Place, Suite A4. Chula Vista, CA 91914. Suggested Use: four tablets two times daily

Figure 2: Each point on the eyelids was stimulated for about one minute with a sqare wave alternating electric current of 206 micro aperes at 10 cycles per second. The eyelid contact was via a wet cotton electrode and the ground was the palms of the subject's hands.

Figure 3. Summary of the data for 25 subjects treated with nutritional supplements and weak electrical stimulation during the period from July '85 to July '92. Subject 11 was dropped from the study when she received a cardiac defibrillator because electrical stimulation might have adversely affected it. Subject 14 suffered severe vision losses after lasering because she had begun to show signs of leakage. One line of acuity is 5 letters.

Supplemental vitamins and minerals (see Figure 1) were assigned to be taken twice per day with meals. During the first 10 weeks the patient was seen 20 times for fundus and acuity examination and for electrical treatments. After this initial period the subject was examined and treated once a month. The electrical treatments of 200 micro amperes were applied to pints on the closed eyelids as shown in Figure 2, for a total of about 7 minutes for each eye using the ElectroAcuscope.

Results
Figure 3 shows the initial age of the subjects who have been in the study from two to seven years. It also shows the duration of involvement, the entering acuity, the acuity at the end and the number of letters change in acuity during the study. For those who have received laser treatment, the final acuity was taken just before lasering. Fifteen subjects improved acuity from 1 to 17 letters and 10 lost 1 to 66 letters. On average a slight reduction of vision occurred during this study amounting to 0.3 letters where 5 equals one line of test letters.

Discussion
To evaluate the results, Newsome's data were used for comparison. The visual acuity test letter sequence that Newsom used was as follows:
20/10 20/32 20/100
20/12.5 20/40 20/125
20/16 20/50 20/160
20/20 20/63 20/300
20/25 20/80 --

There were five letters in each line. Three lines totaling 15 letters doubles the visual angle of the test letters.

Newsome found that for his 71 untreated control subjects, average age 68 years (42 to 88). 18.3% lost 10 to 14 letters of acuity, 8.45% lost 15 to 18 letters and 7% lost 20 or more letters over a period of 24 months using a standardized visual acuity test.4 Newsome's zine-treated experimental group contained 80 subjects of average age 67.6 (46 to 89) years, of whom 6.25% lost 10 to 14 letters, 5% lost 15 to 19 letters and 2.5% lost 20 or more letters.

Newsome has shown a positive effect of selected nutrients on AMD. The average rate of acuity reduction that Newsome found was 7.1 letters for the control population and 4.1 letters for the test population over a two year period. Our study can be compared to Newsome's because our study uses similar visual acuity criteria, the same diagnostic procedures , and includes pharmacological dosages of supplemental zinc.

The possibility of a Hawthorn effect causing an improvement in visual acuity was considered. In situations where the rewards are high as in a driver license test, the acuity test must be randomized to obtain accurate acuity measures. However, when the subject is concerned about permanent vision loss, we believe that learning the charts will have minimal effect on acuity measures.

According to Lane, “the dry type of AMD is different from the wet type and is related to inadequate amounts of zinc. If the wet type AMD subjects had been omitted from this study the results would have shown a gain rather than a loss. We did not do this because

Newsome did not do it.
There have been no reported adverse effects either from the nutritional supplements or the electrical stimulation. Subjects are protected by examinations once a month. In the event of fondus leakage, these months examinations assure early detection and immediate referral to the retinal specialist and laser expert. These professionals and the subject then decide whether to proceed with laser therapy.

Conclusion
This is a preliminary report of an ongoing study, and so far the results are very encouraging. On average, the subjects have shown only a slight reduction in visual acuity. By comparing this study to Newsome's study, it appears that adding electrical stimulation has improved the ability of nutritional supplements to slow the progression of AMD. To permit a proper statistical evaluation more subjects are needed. Thus the experiment is continuing for another four to five years.

References
1National Eye Institute: Vision Resources – A national Plan : 1983-1987. Vol 1.
2NIH Publication 83-2471. Bethesda MD: US Dept Health Human Serv. 1984.
3Newsome DA. Swarz M. Leone NO. Fiston RC. Miller Oral zinc in macular degeneration. Arch. Opinthalmol. 106:192-198. 1988
4Macular Photocoagulation Study Groups Argen laser photo-caoagulation for senile macular degeneration. Arch. Ophthalmol 100x912-918. 1982
5Ferris FL III Kassoff A. Bresnick GB Bailey I. New visual acuity chart for clinical research Am. J. Ophthalmol. 94:91-96. 1982
6Electro-Acuscope. Current Medical Instruments Inc., 135 Kessler Street. Petaluma, California 94952
7Lane BC: Invest. Ophthalmol. Vis. Sci. 3214, Supply 1050. abstr.=1876, 1991.