EFFICIENCY OF DIADENS APPARATUS IN PATIENTS SUFFERING FROM DISEASES OF RETINA

Martino L. EFFICIENCY OF ELECTROSTIMULATION WITH THE HELP OF DIADENS-T APPARATUS IN PATIENTS SUFFERING FROM DISEASES OF RETINA // Collected materials of international symposium devoted to 10-th anniversary of DENAS MS Corporation Moscow, February 14th 2008. c. 17-22.

EFFICIENCY OF ELECTROSTIMULATION WITH THE HELP OF DIADENS-T APPARATUS IN PATIENTS SUFFERING FROM DISEASES OF RETINA

L. De Martino
University Center of Study IPOVISION, Bologna, Italy

Alternative medicine in the ophthalmology field is widely adopted in treatment of different pathological conditions: from dry eyes syndrome to pathology of retina, and especially, pigmentary retinopathy, gerontal central degeneration, degenerative myopia, glaucoma, optic nerve atrophy.

Purpose of our research is to evaluate an efficiency of electrostimulation with the help of DiaDENS-T apparatus in patients suffering from diseases of retina.

Materials and methods. The research was carried out in the period from May to September of year 2006; 10 patients were included into it: 8 women and 2 men; average age was 58.2 ± 17 years (27-76 years old). All the patients suffer from retinal pathology of degenerative type, particularly: pigmentary retinopathy (RP), senile direct degeneration (DMS), atrophic and vascular, glaucomal neuropathy (NOG) (table 1).

Table 1

All the involved patients had either severely impaired vision or impaired vision of the average degree.

Criteria of the inclusion to the research: visually impaired patients with AV < 3/10 (logMAR 0.54) with the fields of view <30%; with the stable retinal pathology which existed not less than 9 months; absence of inflammatory eye diseases in an acute condition.

Elimination criteria: presence of the heart pacemaker, metal clamps or other material sensitive to electromagnetic stimulation, including the ones that are results of surgical interventions; surgical interventions in the eyes for the last 6 month.

The following examinations were done to all the patients in the beginning and in the end of treatment: acuity of vision determination (AV) into the distance and close to the object, biomicroscopy of the posterior segment, intraocular pressure measuring with the help of Goldmann device, fundus of the eye examination.

Parameters that are being estimated: AV p.1 and p.v., microperimetry (microperimeter МР-1 Nidek Technologies, Italy), fields of vision Н:30 (HFA II) and optic coherence tomography (OCT II ZEISS) – in case of microperimetry implementation impossibility (single patient). Microperimetry data, compliancy of the patients and quality of life improvement were evaluated not only in terms of visual acuity, but first of all in respect of personal everyday habits preservation and fulfilment of ordinary obligations.

All the patient were informed about an experimental character of the treatment and gave a written consent.

Patients were evaluated at the beginning of treatment (t-0); 1 week later, 3 weeks later and then 6 weeks after the treatment was started.

Patients received dynamic electroneurostimulation (DENS) with the help of DiaDENS-DT electrostimulator and remote paraorbital electrode DENS-glasses in accordance with the methods presented:

1. Patient sit down comfortably, on the paraorbital area a remote electrode DENS-glasses was applied, which was connected with DiaDENS-T apparatus;
2. DiaDENS-T was set up in a “therapy” mode at 20 or 60 Hz stimulation frequency at a comfortable application intensity;
3. The treatment continued 10-15 minutes during 3 to 5 days a week.

During the treatment it is necessary to make sure that all the electrodes of DENS-glasses tightly abut on the skin in order to prevent apparatus disconnection. Average duration of the treatment with the help of apparatus made up 8±2 weeks.

Results. 9 people out of 10 involved patients finished the treatment, only one patient left the research after the third week of treatment because of personal reasons. We carried out a classical perimetry instead of microperimetry for one of the patients.

No unfavorable results were determined during the control process. Perceptiveness of treatment with the help of DiaDENS-T apparatuses was great.

At the end of every week of treatment patients made a report where they had to include some data about their degree of satisfaction of the accomplished treatment, unpleasant sensations and complications presence.

No one out of 10 patients found the treatment to be burdensome or painful; 8 people stated that they were very pleased with the treatment; 2 people were satisfied with it. By the end of the treatment 7 patients described the state of an eye comfort, reduction of edema in a paraorbital zone among the experienced sensations.

Patients that suffered from pigmentary retinopathy (С.R., N.D.) and had big eyesight deficiency and tubular field of vision noted that they started to see more light and better distinguish objects and people’s features after the treatment.

Patient N.K., that suffered from optical subatrophy as a result of postalcoholic neuropathy noticed, that owing to the treatment he managed to read easier with the help of the support for visually impaired people. We also registered increase of reading speed of this patient.

AV of 4 patients was steady during long period of time without any signs of deterioration when evaluating acuity of vision parameters; no statistically significant changes were registered. 4 patients among the rest noticed a visual acuity improvement; they managed to read 3 letters out of 5 of the same Snellen line, and 2 patients noticed AV improvement of one Snellen line.

Microperimetry allowed us to evaluate DENS treatment efficiency in time taking into consideration, first of all, qualitative and quantitative fixation evolution on the basis of retinal sensitivity.

All the patients who suffered from atrophic and vascular DMS (А.Т., R.S., G.F.) demonstrated presence of absolute scotoma in the atrophied retina area or subretinal blood supply at t-0 with unstable peripheral fixation when having micrioperimetry done. Microperimetry evaluation of these patients on the 1-st, 3-d and 6-th week of treatment demonstrated stabilization of retinal point of fixation (PRL).

Difference between stability of fixation at t-0 and after 6 weeks gave a statistically significant result (р=0.004). Density of points of fixation in 2 g. decreased in some cases and stayed permanent in others.

Peripheral fixation of patients who suffered from pigmentary retinopathy with big eyesight deficiency (<1,30 logMAR) appeared to be unstable during all the time without significant changes before and after 6 weeks of treatment.

One patient who suffered from pigmentary retinopathy (L.G.) did not have a chance to have a microperimetry because a nystagmus was detected, and that hampered the eye movements. In spite of the difficulties caused by nystagmus, an automatic perimetry was carried out for this patient, field of vision was Н:30 (Heidelberg) and ОСТ (Zeiss II) before the treatment and on the 6-th week.

Reduction of depth of scotomas was registered in 2 patients because they perceived the stimulus in stated zones with the reduced intensity. Retinal sensitivity of the rest 8 patients stayed unchanged with the stimulus of the same intensity.

Retinal sensitivity analyses demonstrated that some zones with the atrophy of eye grounds could have certain functionality, and this functionality could grow due to DiaDENS-T apparatus stimulation. Improvement of retinal sensitivity was registered in 2 patients, though this is not a statistically significant result.

Time, that was necessary for examination implementation, was one more parameter that we evaluated when having microperimetry done. All the patients (100 %) showed progressive reduction of time that was necessary for microperimetrical research accomplishment, in average from 15.19 ±2.25 min at t-0 to 14.25 ±2.63 min, 13± 2.60 min, 11 ±2.73 min correspondingly after 1, 3 and 6 weeks of treatment.

The difference of average time of examination implementation at t-0 and 6 weeks of treatment is statistically reliable (р < 0.001).

Discussion of the results.

It is important to remember that we involved patients with severe and average degree of a disease, and their eyesight deficiency was at the severe stage of the disease. All the patients that were chosen for our research suffered from retinal pathologies.

It becomes apparent from our research that electrostimulation of the area around the eyes is able to improve PRL stabilization, but does not reliably improve a visual acuity. A significant PRL stabilization is achieved after timely rehabilitation which follows from the purpose of our research.

We can affirm that DENS treatment is able to impact very different pathogenetic mechanisms that underlie degenerative retinopathy and could positively influence them.

The results that were achieved, possibly, could be explained through metabolic processes increase and retinal sensitivity improvement, as it is seen from the results of microperimetry of 2 patients.

As far as transcutaneous electrostimulation, apparently, impacts an optic blood supply and cellular metabolism, such treatment could slow down progression of degenerative diseases that are characterized by metabolic cellular disfunction.

DENS apparatuses could be very important also for glaucomal neuropathy and for EPR-photoreceptors defense when having pigmented retinitis and senile direct degeneration.

DENS effect is high in treatment and prevention of degenerative retinal disorders. Some mechanisms of action could differently affect the reasons of physiopathology of degenerative retinal disorders that we researched.

Electrostimulation of area around the eyes should be considered an efficient therapy not only for rehabilitation of visually impaired people but also as an auxiliary therapy for prevention and treatment of degenerative retinal pathology.

Practicality of DiaDENS-T apparatus and application convenience of special remote electrodes in a form of glasses make the treatment to be extremely simple and original in comparison with other TENS devices.

Considering the experimental character of the research, we do not yet advise to apply this therapy without the control of ophthalmologist. Though in a future, when enough experience would be accumulated, it would be possible to apply DENS at home.

As a wish. It is necessary to extend our research and increase the number of patients in order to evaluate an efficiency of the therapy also in the environment of visual acuity improvement with all the variants of retinal pathology.