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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-06-17

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye Sjogren's Syndrome Aqueous Tear Deficiency Meibomian Gland Dysfunction Dry Eye Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study will include 30 patients enrolled in 2 stages.

1. The first 15 patients are treated in the more severe dry eye conditioned eye.
2. The remaining 15 patients will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RMS treatment

Group Type EXPERIMENTAL

Ocular Repetitive Magnetic Stimulation (RMS) treatment

Intervention Type 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.

Interventions

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Ocular Repetitive Magnetic Stimulation (RMS) treatment

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No