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

NCT02300818 | Unknown Phase 1 DMC

• 1 other identifier: 20141110
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Hypertension Ocular

Keywords

Hipertension ocular, Glaucoma, Magnetotherapy, seawater

Outcome Measures

Primary Outcomes (1)

• Intro-ocular pression after magnetic field exposition

  Pulsed Electromagnetic Field Therapy

  12 weeks

Study Arms (2)

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.

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

Drug: Seawater eyedrops

Interventions

Pulsed Electromagnetic Field Therapy DEVICE

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.

Also known as: Field magnetic in Glaucoma

Pulsed Electromagnetic Field Therapy

Seawater eyedrops DRUG

Eye-drops daily 1 time a day for 12 weeks

Also known as: thalassotherapy ocular

Seawater eyedrops

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• American Society Of Thermalism And Climatology Inc: lead

Study Sites (1)

Gaviota Clinic

Newark, New Jersey, 07105, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Garis Silega

  America Society of thermalism

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Garis Silega

CONTACT

9739006397; drsilega@aol.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (1)