Clinical trial NCT03012698: Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye
Official title: Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Sjogren's Syndrome
Aqueous Tear Deficiency
Meibomian Gland Dysfunction
Dry Eye Syndromes
Lead sponsor: Epitech Mag Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: 3 mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: E. Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center (SZMC)
Study officials:
affiliation: Hadassah Medical Organization
name: Avi Solomon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medical Center
name: David Zadok, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wolfson Medical Center
name: Haggay Avizemer, MD
role: PRINCIPAL_INVESTIGATOR
References: