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

Primary Purpose

Primary Open Angle Glaucoma, Hypertension Ocular

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pulsed Electromagnetic Field Therapy
Seawater eyedrops
Sponsored by
American Society Of Thermalism And Climatology Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Hipertension ocular, Glaucoma, Magnetotherapy, seawater

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • Gaviota ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pulsed Electromagnetic Field Therapy

Seawater eyedrops

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Intro-ocular pression after magnetic field exposition
Pulsed Electromagnetic Field Therapy

Secondary Outcome Measures

Full Information

First Posted
November 14, 2014
Last Updated
June 22, 2015
Sponsor
American Society Of Thermalism And Climatology Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02300818
Brief Title
Effects of Magnetic Therapy and Seawater Combined in Decreasing Intraocular Presion.
Acronym
GME
Official Title
Magneto Therapy in the Therapy of Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Society Of Thermalism And Climatology Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Hypertension Ocular
Keywords
Hipertension ocular, Glaucoma, Magnetotherapy, seawater

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Electromagnetic Field Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Seawater eyedrops
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Pulsed Electromagnetic Field Therapy
Other Intervention Name(s)
Field magnetic in Glaucoma
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Seawater eyedrops
Other Intervention Name(s)
thalassotherapy ocular
Intervention Description
Eye-drops daily 1 time a day for 12 weeks
Primary Outcome Measure Information:
Title
Intro-ocular pression after magnetic field exposition
Description
Pulsed Electromagnetic Field Therapy
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Garis Silega
Phone
9739006397
Email
drsilega@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garis Silega
Organizational Affiliation
America Society of thermalism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaviota Clinic
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garis Silega, Dr
Phone
862-229-4766
Email
drsilega@aol.com
First Name & Middle Initial & Last Name & Degree
Garis Silega, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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