Aqueous Tear Deficiency, Dry Eye, Dry Eye Syndromes, Meibomian Gland Dysfunction, Sjogren's Syndrome
Conditions
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.
Interventions
DEVICEOcular 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.
Sponsors
Epitech Mag Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (BCVA) | 3 mounth |
Countries
Israel
Outcome results
None listed