Primary Open Angle GlaucomaPhase 1/2GMENCT02300818
Effects of Magnetic Therapy and Seawater Combined in Decreasing Intraocular Presion.
A Phase 1/2 study testing Pulsed Electromagnetic Field Therapy and Seawater eyedrops in people with Primary Open Angle Glaucoma and Hypertension Ocular, run by American Society Of Thermalism And Climatology Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma, Hypertension Ocular
- What is being tested?
- Pulsed Electromagnetic Field Therapy and Seawater eyedrops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gaviota Clinic
Newark, New Jersey, 07105
Garis Silega, Dr, 862-229-4766, drsilega@aol.com
Garis Silega, Dr
About this study
Official title: Magneto Therapy in the Therapy of Glaucoma
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.
Read the 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
- Conditions
- Primary Open Angle Glaucoma, Hypertension Ocular
- Being tested
- Pulsed Electromagnetic Field Therapy, Seawater eyedrops
- Keywords
- Hipertension ocular, Glaucoma, Magnetotherapy, seawater
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Field TherapyDevice
Also called Field magnetic in Glaucoma
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.
Seawater eyedropsDrug
Also called thalassotherapy ocular
Eye-drops daily 1 time a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Electromagnetic Field Therapy | Active comparator | 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. Receives: Device: Pulsed Electromagnetic Field Therapy |
| Seawater eyedrops | Active comparator | 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 Receives: Drug: Seawater eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intro-ocular pression after magnetic field exposition
Pulsed Electromagnetic Field Therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Society Of Thermalism And Climatology Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garis Silega, Principal investigator, America Society of thermalism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300818
- Sponsor's protocol ID
- 20141110
- Acronym
- GME
- Status last verified
- Jun 2015
- First submitted
- 14 Nov 2014
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magneto Therapy in the Therapy of Glaucoma
- ClinicalTrials.gov ID
- NCT02300818
- Acronym / sponsor ID
- GME / 20141110
- Conditions
- Primary Open Angle Glaucoma, Hypertension Ocular
- Keywords
- Hipertension ocular, Glaucoma, Magnetotherapy, seawater
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American Society Of Thermalism And Climatology IncUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Electromagnetic Field Therapy | Active comparator | Device: Pulsed Electromagnetic Field TherapyPulsed 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. |
| Seawater eyedrops | Active comparator | Drug: Seawater eyedropsinstantly 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electromagnetic Field TherapyAlso: Field magnetic in GlaucomaPulsed 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. | Device | Pulsed Electromagnetic Field Therapy |
| Seawater eyedropsAlso: thalassotherapy ocularEye-drops daily 1 time a day for 12 weeks | Drug | Seawater eyedrops |
Primary outcome
Intro-ocular pression after magnetic field exposition
Time frame: 12 weeks
Pulsed Electromagnetic Field Therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garis Silega principal investigator
America Society of thermalism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pulsed Electromagnetic Field Therapy and Seawater eyedrops in people with Primary Open Angle Glaucoma and Hypertension Ocular, run by American Society Of Thermalism And Climatology Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Garis Silega (9739006397, drsilega@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intro-ocular pression after magnetic field exposition (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.