Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye

The study aims to test the safety of Repetitive Magnetic Stimulation (RMS) treatment for dry eye disease. Patients are asked to undergo a one-time treatment with Epitech Ocular Magnetic Stimulation Device on one eye in the first stage and both eyes sequentially in the second stage of the study. Changes are monitored for over a study period of 3 months.

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Key information

Conditions

Dry Eye Aqueous Tear Deficiency Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Eyelid Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E. Wolfson Medical Center, Holon, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females, 18-80 years old
Subjects with moderate to severe dry eye syndrome
Subjects able to understand the requirements of the protocol and provide informed consent.

Exclusion criteria

Eyes with other ocular surface pathology which requires more treatment than eye lubricant and conventional eyelid hygiene
A concurrent ocular disease including ocular infection or pterygium.
Ocular surgery within the previous 6 months and LASIK within the previous 1 year.
Any ocular injury or ocular Herpes infection within past 3 months
Anticipated necessity to wear contact lens in the duration of the study.
Unstable thyroid disorders (Drugs Tx not stable in the last 3 months).
Alcoholism
Pregnant or nursing women
Documented HIV positive
Cardiac pacemakers, cardioverter defibrillators, or neurostimulators, cochlear implants, implanted medication pumps or intracardiac lines, implanted brain electrodes (cortical or deep-brain electrodes)
Any Conductive, ferromagnetic or other magnetic - sensitive objects such as aneurysm clips or coils, stents, bullet fragments in the head or neck
Significant heart disease or cerebrovascular disease
History of epilepsy, dementia, head trauma, increased intracranial pressure, or central nervous system (CNS) tumors.
Participation in another ophthalmic clinical trial within past 30 day
Any other specified reason as determined by the clinical investigator.

Treatment and study plan

Ocular Repetitive Magnetic Stimulation (RMS) treatment

Device

First stage: Patients will be asked to undergo a one-time treatment with Epitech Corneal Magnetic Stimulation Device on one eye. The worst eye will be treated; if both eyes are equal, the right eye will be treated.

Second stage: will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.

Primary outcomes

Best Corrected Visual Acuity (BCVA)

Time frame: 3 mounth

Sponsors and collaborators

Lead sponsor

Epitech Mag Ltd.

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Jan 6, 2017
Registry last updated: Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed