Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Magnetic Therapy and Seawater Combined in Decreasing Intraocular Presion. (GME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300818
Recruitment Status : Unknown
Verified June 2015 by American Society Of Thermalism And Climatology Inc.
Recruitment status was:  Recruiting
First Posted : November 25, 2014
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
American Society Of Thermalism And Climatology Inc

Brief Summary:
Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular pressure (IOP) has been identified as the most important risk factor. However, some patients progress despite adequate IOP lowering while some subjects with elevated IOP never develop glaucoma. Other patients develop glaucoma although IOP measurements were always in the normal range. Therefore, other factors must be involved. In the last years, studies using MRI have been performed and evidence has accumulated that also changes in retrobulbar structures are present, in particular in the lateral geniculate nucleus and the visual cortex. However, these studies were limited by the low spatial resolution of the MRI instruments used.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Hypertension Ocular Device: Pulsed Electromagnetic Field Therapy Drug: Seawater eyedrops Phase 1 Phase 2

Detailed Description:

The two principal pathophysiological mechanisms of glaucomatous process (hydromechanical and metabolic) determine the development of two trends in the treatment of glaucoma. One treatment modality is aimed at reduction of intraocular pressure, the other at therapy of hemodynamic and metabolic disorders. General and local drug therapy and physiotherapy, including electro- and laser stimulation of the retina and optic nerve and magneto-therapy, are used to correct these disorders. Modern ocular hypotensive agents are myotics and beta-adrenoblockers, adrenergic drugs, alpha 2-agonists, carboanhydrase inhibitors, some prostaglandins, osmotic agents. The progress attained in conservative therapy of glaucoma should by no means be overstated. In many cases only a combination of conservative and surgical methods of treatment helps preserve vision in a glaucoma patient.

During the following investigation we will demonstrate that the use of Magneto therapy Ocular (MTO) reverses the symptomatology in Glaucoma patients. The use of Eyeglass magnetic prevents the development of Glaucoma disease.During the following investigation we will demonstrate that the use of MTO reverses the symptomatology of Glaucoma patients; the use of seawater as drops prevents the development of Glaucoma disease and the combined use of MTO and seawater is an effective therapy against Glaucoma disease that will cure a grand percentage of the patients.

We will randomized 100 glaucoma patients and will treat them with MTO (group 1) and seawater drop (group 2) and combined group 3 and will compare results


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Magneto Therapy in the Therapy of Glaucoma
Study Start Date : November 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Active Comparator: Pulsed Electromagnetic Field Therapy

Pulsed Electromagnetic Field Therapy widely termed as (PEMF) is a reparative technique used for treatment of eye therapy has proved to be a beneficial treatment for those suffering from glaucoma. This therapy helps in increased blood flow and show positive results on latent, initial and advanced glaucoma with ten sessions of seven minutes' each.

PEMF has also proved to be beneficial in vision acuity of patients with low vision. In 50 per cent of the cases, values improved. Patients with vision acuity of 0.2 diopters showed improvement from 46 before treatment to 75 after treatment.

Different studies on varied diseases have proved that Pulsed Electromagnetic Field Therapy (PEMF) treatment is a safe, non-invasive and effective option for curing ocular conditions.

Device: Pulsed Electromagnetic Field Therapy
Pulsed Electromagnetic Field Therapy widely termed as (PEMF) is a reparative technique used for treatment of eye therapy has proved to be a beneficial treatment for those suffering from glaucoma. This therapy helps in increased blood flow and show positive results on latent, initial and advanced glaucoma with ten sessions of seven minutes' each.
Other Name: Field magnetic in Glaucoma

Active Comparator: Seawater eyedrops
instantly soothes and clears the eye irritation caused by pollution, pollen, smoke, etc. It is a very practical system for eye daily hygiene · enables efficient therapeutic help in basic eye conditions such as: · · internal and external stye blepharitis and keratoconjunctivitis · · Conjuntiviti Episcleritis and scleritis
Drug: Seawater eyedrops
Eye-drops daily 1 time a day for 12 weeks
Other Name: thalassotherapy ocular




Primary Outcome Measures :
  1. Intro-ocular pression after magnetic field exposition [ Time Frame: 12 weeks ]
    Pulsed Electromagnetic Field Therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patient is aged 18 years or older, with glaucoma include poorly controlled open angle glaucoma (Pigmentary & Exfoliative Glaucoma) Patient is willing to participate in the 3-month study and to adhere to the follow-up schedule.

Patient is willing to review and sign a consent form.

Exclusion Criteria:

Prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.

Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.

Patient is pregnant. Patient might require other ocular surgery within the 6-month follow-up period. Having concurrent treatment with systemic steroids. Patient is under 18 years old -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300818


Contacts
Layout table for location contacts
Contact: Garis Silega 9739006397 drsilega@aol.com

Locations
Layout table for location information
United States, New Jersey
Gaviota Clinic Recruiting
Newark, New Jersey, United States, 07105
Contact: Garis Silega, Dr    862-229-4766    drsilega@aol.com   
Principal Investigator: Garis Silega, Dr         
Sponsors and Collaborators
American Society Of Thermalism And Climatology Inc
Investigators
Layout table for investigator information
Principal Investigator: Garis Silega America Society of thermalism

Layout table for additonal information
Responsible Party: American Society Of Thermalism And Climatology Inc
ClinicalTrials.gov Identifier: NCT02300818     History of Changes
Other Study ID Numbers: 20141110
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by American Society Of Thermalism And Climatology Inc:
Hipertension ocular, Glaucoma, Magnetotherapy, seawater

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions