LipiFlow® and LipiView® FAQs

Indications for Use

The LipiView® 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, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer.

Contraindications

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 the LipiView® Interferometer.

Precautions

The following patient conditions may affect the interferometry assessment of a patient’s tear film using the LipiView® Interferometer:

  • Use of ophthalmic drops such as artificial tear lubricants, ointments, and medications. Do not instill oil-based ophthalmic drops (e.g., Soothe®, Restasis®) for at least 12 hours prior to device use and do not 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. 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. Do not to swim for atleast 12 hours prior to device use.
  • Any ocular surface condition that affects the stability of the tearfilm. These conditions include disease, dystrophy, trauma, scarring, surgery, or abnormality.

Potential Adverse Effects

There are no known or anticipated adverse effects associated with use of the LipiView®.

The LipiView® Interferometer does not physically touch the eye. Light exposure is at safe levels for observation of the tear film and image capture.

 

MEIBOMIAN GLAND EVALUATOR™

Indications for Use

The Meibomian Gland Evaluator™ is intended for use by a physician to evaluate meibomian gland secretions.

Contraindications

No contraindications are known.

Precautions

  • 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.

Potential Adverse Effects

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

Indications for Use

The LipiFlow® 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.

Contraindications

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 three months, including intraocular, oculo-plastic, corneal or refractive surgery procedure
  • Ocular injury within prior three months
  • Ocular Herpes of eye or eyelid within prior three months
  • Active ocular infection e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye
  • Active ocular inflammation or history of chronic, recurrent ocularinflammation within prior three months e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis
  • Eyelid abnormalities that affect lid function e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis
  • Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy

Precautions

The Disposable may not fit all eyes, such as eyes with small palpebral fornices. Use of the LipiFlow® System is not recommended in patients with the following conditions. Patients with these conditions may have reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands. 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

In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.

Potential Adverse Effects

In the randomized, controlled clinical study, there were no serious adverse events related to the use of the LipiFlow® System. The non-serious device-related adverse events for the LipiFlow® System included moderate eyelid pain and moderate conjunctival hyperemia or vascular injection. Other slit lamp findings included eyelid hyperemia, eyelid edema, conjunctival petechial hemorrhages, conjunctival chemosis or edema, superficial punctate epithelial keratopathy, ocular surface staining, and discharge or mucus in the tear film. These non-serious adverse events and slit lamp findings were temporary and resolved during the four-week study without any permanent effect or need for medical treatment.

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 e.g., edema, dermatitis, hordeolum or chalazion
  • Ocular surface irritation or inflammation e.g., corneal abrasion, conjunctival edema or conjunctival injection (hyperemia); and
  • Ocular symptoms e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light

Potential serious adverse events 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;
  • Ocular surface infection.