Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction

Exclusion Criteria

• •1. Evidence of co-existing ocular conditions potentially posing an increased risk of procedure-related injury, (e.g., active ocular infection or inflammation in either eye)
• •2. History of ocular trauma or surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year
• •3. Ocular surface abnormality potentially compromising corneal integrity in either eye; eyelid abnormalities affecting lid function in either eye
• •4. Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren's syndrome)
• •5. Unwillingness to abstain from systemic medications known to cause dryness for the study duration.
• •6. Individuals who have either changed the dosing of systemic or non-dry eye/MGD ophthalmic medication within the past 30 days prior to screening
• •7. Internal defibrillator, a pacemaker or any other implanted electrical device anywhere in the body
• •8. Permanent metal implant in the treatment area
• •9. Any surgery in the treatment area in the last 3 months
• •10. Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
• •11. Pregnancy and nursing or females of childbearing potential and not utilizing adequate birth control measures
• •12. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
• •13. Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
• •14. Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary, and hormonal virilization
• •15. Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes, and rash.
• •16. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
• •17. Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
• •18. Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• •19. Participation in another study within 30 days prior to screening.
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