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Results of the First 120 People Treated with MCS

DISCLAIMER

The data presented here has not been reviewed by the FDA, nor has it been peer reviewed. The microcurrent devices used are approved by the FDA for the treatment of pain, but they have not been approved for other uses. The use of a device for an off-label use by a physician is legal. The use of microcurrent stimulation discussed here is only one part of a comprehensive program for supporting visual health. Dr. Miller is not a manufacturer of these devices, and the material presented here is informational, and is not intended as simply a solicitation to sell devices.

If you have further questions about the work being done by Dr. Miller, please contact his office to arrange an appointment or consultation.

We have been treating people with retinal disease in this office for two years now, and we have just analyzed the results from the first 120 patients that we have treated. The results have been quite gratifying. One surprise that we find in analyzing the data is how well the people with the wet form of aged-related macular degeneration have responded. The conventional wisdom that was given to Dr. Miller when he first started doing these procedures was that the patients with "wet" macular degeneration (exudative macular degeneration) did not respond as well as those with "dry" macular degeneration (non-exudative macular degeneration). This data shows that patients with exudative macular degeneration respond quite positively.

The data reflects improvements as measured in visual acuity testing. Many of these patients have also shown improvement in their visual fields and in scoring on color testing, but follow up data in these areas was not consistently available. Acuity testing was available for all the patients we have seen and so that is what we present here.

The other very pleasant surprise was how well the patients with Stargardt's Disease have responded to microcurrent stimulation therapy.

Below is data for the numbers of patients treated with various diagnoses. Some of this data does not give the clearest reflection of the actual results for a variety of reasons. Most patients with macular degeneration show variation in the time of onset and the progression of the disease between their two eyes. Many of the patients who have the wet or exudative form of the disease have only had problems with leaking or bleeding in one eye and not the other while some have shown evidence for leaking or bleeding in both eyes. Two patients were blind in one eye for reasons entirely unrelated to their macular degeneration. For these and other reasons, we also present the data in terms of the number of eyes treated. This gives a better sense of the differential response between those eyes with the exudative form of macular degeneration and the response of those eyes with the non-exudative form of macular degeneration.

Visual acuity testing, if carefully done, is a reasonable and repeatable measurement of one aspect of a person's vision. In any given person however there can be variations in visual acuity on a day to day basis due to such things as the overall state of their health, presence or absence of upper respiratory infections, quality and extent of the previous night's sleep, level of stress, etc. These variations however are seldom more than one line of change on a visual acuity chart. Because of these variations, and in part to allow this data to correspond to data reported by other practitioners who are using microcurrent stimulation for the treatment of retinal disease, I have chosen to consider two lines of improvement or change on a visual acuity chart to be necessary to call a result clinically significant. If the person's vision is improved by two lines or more as measured in visual acuity testing, this is probably significant, and not due to random fluctuation.

Results

Of all 120 patients treated, 83% (101/120) showed improvement of greater than or equal to two lines of visual acuity in one or both eyes. If we include those who had at least one line of improvement in visual acuity, then 93% showed improvement.

There were 11 patients (11 of 120) with Stargardt's Disease who were treated and of these all 11 or 100% showed an improvement of greater than or equal to two lines of visual improvement in one or both eyes. There was one patient (1 of 120)who had the diagnosis of X-linked Retinoschisis and they also showed two lines of improvement on visual acuity testing in both eyes.

If we take the 109 patients with aged-related macular degeneration (ARMD) and break them down by diagnosis type into exudative (wet) and non-exudative (dry) we find that of the patients with wet ARMD 88% (43/49) showed an improvement of two lines or greater on visual acuity testing and of those with dry ARMD, 77% (46/60) showed improvement of two lines or more on visual acuity testing.

Results by Eyes

The tables that follow show the results by number of eyes treated for patients with ARMD, Stargardt's and for the Total Eyes treated.

By doing some simple arithmetic on the data on the tables, we can see that of the eyes treated, the total for all eyes with non-exudative disease was 36% with an improvement of three lines or greater on a visual acuity test and for those with exudative disease, 53% showed improvement of three lines or greater on visual acuity testing following treatment. The patients who had greater than or equal to four lines of improvement on visual acuity testing was also quite gratifying with 22% improving with the dry form of the disease and 32% improving with the wet form of the disease.

In the limited data reported in conferences by others doing this work (Halloran 1997, Jarding 1997) there had been evidence for significant slowing and stopping of the progression of disease in those treated and followed over many years. If there was improvement as the result of treatment, this improvement was maintained, and even where there was no significant improvement, the vision stabilized and the stabilization persisted as long as treatment was continued. I have not been treating people long enough to comment on this from my own data, but as the data reported above is similar and in some cases better than the results reported by others, I would expect that as I continue to follow these patients, these results will remain stable.

Of all the patients and all the eyes treated, there were 7 eyes that showed a worsening of one line as tested by visual acuity testing or 3% of the eyes. There were 3 eyes (in 3 patients) that showed a worsening of two lines of visual acuity which is possibly significant but representing only 1% of the eyes treated. No one had worsening of greater than two lines as determined by visual acuity testing. In all of these patients who have shown worsening, the data that I have comes from the first weeks of treatment. These patients live distant to the office and we have not been able to do follow up testing. There was no evidence of retinal hemorrhage in any of these patients who showed worsening. We would have preferred to find when we analyzed the data that there were no patients who showed any worsening but we are still satisfied that the procedure is safe. Data from some of the research on the effects of supplements on ARMD give us an idea of the natural history of the progression of this disease in populations of people, and this data suggests that the percentage of people showing worsening of their vision in a population such as the one we studied would be far higher. The data also tells us that the percentage of people we are seeing with improvements is a result of their treatments with microcurrent stimulation therapy. As we continue with treatments, continued efforts are being made to try and understand why some people respond better than others and we will continue to strive to improve the protocols and techniques.

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From the Office of Damon P. Miller II, M.D., N.D.
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