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Multicenter Study of the Efficacy and Safety of Bio-informational Therapy in the Treatment of Functional Vision Disorders
Clinical Data Gatering
Those patients who accept responsibility for their own level of well-being and those healthcare professionals who treat the whole person rather than focus on a specific illness or a part of the body exercise so called holistic approach to medical treatment accounting for the overall physical, mental, spiritual, and emotional state of a patient. According to a holistic approach, all systems comprising the whole body are interdependent, and a disease is seen as an impairment of the balance in the body’s systems.
Such approach is applicable to the vision functionality too. Anyone having pain or being too hungry or having impaired sugar metabolism or psychological changes, or any kind of vegetative dystonia etc. will suffer certain disturbances of vision. Traditional Chinese medicine shows interconnections between the vision and different meridians, e.g., liver, stomach or pancreas meridians, or triple warmer meridian controlling the hormonal functionality or pericardium meridian responsible for circulatory changes. Thus, to achieve a healing effect with respect to vision, one has to restore the balance in the whole body. This means a need in the restoration of the traffic capacity of pathways for signals carrying within the body the biologically important information in relation to vision functionality.
Today, a holistic approach to the treatment of vision disorders may be implemented owing to a development of methods and devices that make it possible to measure different bioinformatic signals of the body and to apply such signals for the purposes of restoration of inherent physiological mechanisms controlling the vision. Wellness devices employed in this study (Lenyo LuxTM and FractalTM developed and manufactured by Hippocampus-BRT Ltd. sponsoring this study) are preset to facilitate signal transduction over the mentioned meridians influencing the visual functions. Employment of such devices in the wellness and complementary medical practice for several past years has shown fascinating good results. Therefore, we start this pilot multicenter study in order to collect sufficient evidence that will encourage acknowledged university clinics to make broad and detail clinical trials of the efficacy and safety of bio-informational treatment of vision disorders.
Project description
Daily session:
• Two treatments administered in series without a time interval between the treatments will be administered either by using Lenyo Lux device (‘short’ program number 111) or Fractal device (duration of one treatment – about 12 minutes). A big pad and local applicator will be used. Duration of each session shall be 24.5 minutes
• Visual acuity test will be performed in accordance with guidelines shown in the Annex once weekly immediately before and after the treatment. Results of such examination of a patient will be registered in the Individual Registration Form of such patient.
• The aforementioned daily treatment will be administered 5 times per week for 16 weeks. Data for only those patients who will undergo the 16-week course of bio-informational treatment within not more than 20 weeks after the first session will be included in the further analysis.
• Questionnaires containing questions in relation to the quality of vision and the general state of the metabolism will be filled in during weekly examinations (altogether 17 filled questionnaires per patient).
Study doctors:
• Study doctors shall sign a contract with Hippocampus Institute and get instructions about the examination procedures.
• Since the treatment administered in the course of this study is not a medical treatment but aimed at an improvement of biocommunication in the tissues involved in the vision functionality rather than at a local treatment of the eye, study doctors shall not necessarily be ophthalmologists but they shall have a good work contact with the ophthalmologists in charge of the study for consulting purposes.
• Study doctors’ name will be mentioned in the final peer reviewed publication.
• Study doctors will have an option to purchase a required device at discount.
Participants of the study:
• Participants eligible for this study will be selected on the basis of inclusion and exclusion criteria described in detail in the study questionnaire.
• There is no age limitation for participants in this study.
• Subjects having a treatment device or having purchased such device (at discount – for those who participate in this study) can continue treatment outside of ordination (at home, on the work place, etc.).
Such approach is applicable to the vision functionality too. Anyone having pain or being too hungry or having impaired sugar metabolism or psychological changes, or any kind of vegetative dystonia etc. will suffer certain disturbances of vision. Traditional Chinese medicine shows interconnections between the vision and different meridians, e.g., liver, stomach or pancreas meridians, or triple warmer meridian controlling the hormonal functionality or pericardium meridian responsible for circulatory changes. Thus, to achieve a healing effect with respect to vision, one has to restore the balance in the whole body. This means a need in the restoration of the traffic capacity of pathways for signals carrying within the body the biologically important information in relation to vision functionality.
Today, a holistic approach to the treatment of vision disorders may be implemented owing to a development of methods and devices that make it possible to measure different bioinformatic signals of the body and to apply such signals for the purposes of restoration of inherent physiological mechanisms controlling the vision. Wellness devices employed in this study (Lenyo LuxTM and FractalTM developed and manufactured by Hippocampus-BRT Ltd. sponsoring this study) are preset to facilitate signal transduction over the mentioned meridians influencing the visual functions. Employment of such devices in the wellness and complementary medical practice for several past years has shown fascinating good results. Therefore, we start this pilot multicenter study in order to collect sufficient evidence that will encourage acknowledged university clinics to make broad and detail clinical trials of the efficacy and safety of bio-informational treatment of vision disorders.
Project description
Daily session:
• Two treatments administered in series without a time interval between the treatments will be administered either by using Lenyo Lux device (‘short’ program number 111) or Fractal device (duration of one treatment – about 12 minutes). A big pad and local applicator will be used. Duration of each session shall be 24.5 minutes
• Visual acuity test will be performed in accordance with guidelines shown in the Annex once weekly immediately before and after the treatment. Results of such examination of a patient will be registered in the Individual Registration Form of such patient.
• The aforementioned daily treatment will be administered 5 times per week for 16 weeks. Data for only those patients who will undergo the 16-week course of bio-informational treatment within not more than 20 weeks after the first session will be included in the further analysis.
• Questionnaires containing questions in relation to the quality of vision and the general state of the metabolism will be filled in during weekly examinations (altogether 17 filled questionnaires per patient).
Study doctors:
• Study doctors shall sign a contract with Hippocampus Institute and get instructions about the examination procedures.
• Since the treatment administered in the course of this study is not a medical treatment but aimed at an improvement of biocommunication in the tissues involved in the vision functionality rather than at a local treatment of the eye, study doctors shall not necessarily be ophthalmologists but they shall have a good work contact with the ophthalmologists in charge of the study for consulting purposes.
• Study doctors’ name will be mentioned in the final peer reviewed publication.
• Study doctors will have an option to purchase a required device at discount.
Participants of the study:
• Participants eligible for this study will be selected on the basis of inclusion and exclusion criteria described in detail in the study questionnaire.
• There is no age limitation for participants in this study.
• Subjects having a treatment device or having purchased such device (at discount – for those who participate in this study) can continue treatment outside of ordination (at home, on the work place, etc.).
