Getting to the Glandular Level with Dry Eye
INDICATIONS AND IMPORTANT SAFETY INFORMATION for LIPIFLOW® Thermal Pulsation System
The LipiFlow® Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
Do not use the LipiFlow® System in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.
• Ocular surgery within prior 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure
• Ocular injury within prior 3 months
• Ocular herpes of eye or eyelid within prior 3 months
• Active ocular infection
• Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
• Eyelid abnormalities that affect lid function
• Ocular surface abnormality that may compromise corneal integrity
The Activator or Activator II (Disposable) may not fit all eyes, such as eyes with small palpebral fornices.
Use of the LipiFlow® System in patients with the following conditions may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and effectiveness of the device have not been studied in patients with these conditions.
• Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
• Severe (Grade 3 or 4) eyelid inflammation (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis). Patients with severe eyelid inflammation should be treated medically prior to device use.
• 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, Sjögren's syndrome)
• Taking medications known to cause dryness (e.g., isotretinoin (Accutane®) and systemic antihistamines)
• Esthetic eyelid and eyelash procedures (e.g., blepharoplasty, lash extensions, eyelid tattooing)
In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.
Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in:
• Eyelid/eye pain requiring discontinuation of the treatment procedure;
• Eyelid irritation or inflammation;
• Ocular surface irritation or inflammation; and
• Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light).
Potential serious adverse events (defined as permanent impairment or damage to a body structure or function or necessitates medical or surgical intervention to preclude permanent impairment or damage to a body structure or function) that are not anticipated because of the device mitigations to prevent occurrence include:
• Thermal injury to the eyelid or eye, including conjunctiva, cornea or lens;
• Physical pressure-induced injury to the eyelid; and
• Ocular surface (corneal) infection.
Reference the LipiFlow Thermal Pulsation System Instructions for Use for a complete listing of indications, warnings, and precautions.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for LIPISCAN® Dynamic Meibomian Imager
LipiScan® Dynamic Meibomian Imager (DMI) is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.
No contraindications have been identified for the LipiScan®.
Caution: Disinfect the surfaces of the chin rest, forehead rest and Handheld Near Infrared (IR) Lid Everter with isopropyl alcohol immediately prior to use and prior to storage to prevent cross-contamination and patient infection.
Warnings include any potential hazards for adverse events to the patient or user. Review the warnings in Table 1 of the LipiScan® Dynamic Meibomian Imager Instructions for Use prior to using LipiScan®.
There are no known or anticipated adverse effects associated with use of this device.
Reference the LipiScan® Dynamic Meibomian Imager Instructions for Use for a complete listing of indications, warnings, and precautions.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for LIPIVIEW® II Ocular Surface Interferometer
The LipiView® II Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of Specular (interferometric) observations of the tear film. Using these images, LipiView® II measures the absolute thickness of the tear film lipid layer, Meibomian glands under near-infrared (NIR) illumination, and the ocular surface and eyelids under white illumination.
Contraindications are conditions in which the device should not be used because the risk of use clearly outweighs any benefit. No contraindications have been identified for LipiView® II.
The following patient conditions may affect the interferometry assessment of a patient’s tear film using LipiView® II:
• Use of ophthalmic drops such as artificial tear lubricants, ointments, and medications. Advise patients not not instill oil-based ophthalmic drops (e.g., Soothe ®, Restasis®, Systane Balance®) for at least 12 hours prior to device use and not to instill ointments for at least 24 hours prior to device use. Wait at least four (4) hours after the instillation of all other ophthalmic drops prior to device use.
• Soft or rigid contact lens wear. Advise patients to remove contact lenses at least four hours prior to device use.
• Use of oil-based facial cosmetics around the eye.
• Eye rubbing.
• Recent swimming in a chlorinated pool. Advise patients to not to swim for at least 12 hours prior to device use.
• Any ocular surface condition that affects the stability of the tear film. These conditions include disease, dystrophy, trauma, scarring, surgery, or abnormality.
There are no known or anticipated adverse effects associated with use of this device.
Reference the LipiView® II Ocular Surface Interferometer Instructions for Use for a complete listing of indications, warnings, and precautions.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for MEIBOMIAN GLAND EVALUATOR (MGE)
The Meibomian Gland Evaluator is a hand held instrument used by a physician to evaluate Meibomian gland secretions in adult patients during a routine eye examination. The instrument provides a standardized method to apply consistent, gentle pressure to the outer skin of the lower eyelid while visualizing the secretions from the Meibomian gland orifices through a slit lamp biomicroscope.
No contraindications are known.
• Do not depress the shaft to the endpoint of the spring. Do not apply any additional force after the shaft has been depressed approximately 6 mm. Applying additional force negates the benefit of using the instrument to apply standard force.
• Familiarity with use of a slit lamp biomicroscope is required to use Meibomian Gland Evaluator for assessment of the meibomian gland secretions.
To ensure proper use of the Meibomian Gland Evaluator, review the warnings below.
• Do not use Meibomian Gland Evaluator if the package is open or broken. Do not use Meibomian Gland Evaluator if it appears broken or has sharp edges or rough surfaces upon initial inspection.
• Maintain proper infection control procedures including cleaning hands before handling the device and before evaluation of each patient. Disinfect the instrument with alcohol after each use and between patients.
• Avoid contact of the devices with the eye. Instruct the patient to look up and away to avoid injury to the cornea in the event the contact surface inadvertently touches the eye.
Potential adverse effects that are unlikely but may occur with use of the Meibomian Gland Evaluator include but are not limited to:
• Skin abrasion (e.g., from a rough surface on the device)
• Eye abrasion (e.g., from improper contact of the instrument with the eye)
• Infection of the skin or eye (e.g., from improper or lack of disinfection after use and between patients)
• Allergic or toxic reaction (e.g., from exposure to any residue on device during user handling)
Reference the Meibomian Gland Evaluator Package Insert for a complete listing of indications, warnings, and precautions.