Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective, Randomized, Controlled Comparison of an Automated Thermal Pulsation Treatment (Lipiflow ®) and a Standard Lid Hygiene Regime
Brief Summary: Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated thermal pulsation with the Lipiflow® system have been reported in several case reports. In one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. However, treatment recommendations for lid hygiene according to the MGD-report consist of hyperthermia followed by lid massage and lid margin cleansing over several months. To the best of the investigators knowledge this is the first randomized prospective study to compare automated thermal pulsation treatment with the new Lipiflow ® system with a standard lid hygiene regime.

The investigators suggest that a single treatment with Lipiflow® is superior to a lid hygiene regime.


Options:
A: Inclusion Criteria:

* Men or women ≥18 years old
* Patients affected by age-related cataract \<3 according to the Lens Opacities Classification System III scale (LOCS III)
* Meibomian gland dysfunction (MGD) diagnosed using slit lamp examination, following the criteria reported in the paper Arita R. et al, Am J Ophthalmol. 2016 Sep;169:125-137.
* Fluorescein tear BUT \<7 seconds

Exclusion Criteria:

* Subjects with documented history and / or clinical signs of concomitant presence of an eye infection caused by viruses such as herpes simplex virus (HSV) or fungi in the previous 3 months.
* Patients with anterior blepharitis or Demodex
* Meibomian gland atrophy score greater than 2/3
* Subject treated with drugs that can have effects on MGD prior to inclusion in the study
* Active ocular inflammation or history of chronic eye inflammation recurrent in the previous 3 months (e.g. retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)
* Eyelid abnormalities affecting eyelid function (entropion, ectropion, neoplasia, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
* Abnormalities of the ocular surface that compromise the integrity of the cornea (e.g.

previous chemical burn, recurrent corneal erosion, corneal epithelial defect, corneal dystrophy)

* Subjects who underwent eye surgery in the previous 3 months, including intraocular, oculo-plastic, corneal or refractive surgery
* Patients suffering from diabetes mellitus, rheumatism, immune diseases and other serious systemic diseases
* Pregnant or lactating women
B: Inclusion Criteria:

* Understand and sign an Informed Consent document;
* Have Meibomian Gland Dysfunction with evaporative dry eye disease at the screening visit;
* Agree not to wear contact lenses for the duration of the study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

* History of eye surgery, as specified in the protocol;
* Eye infection or inflammation, as specified in the protocol;
* Eyelid abnormalities; eyelid tattoos;
* Treated with LipiFlow or iLux in either eye in the last 12 months;
* Contact lens wear within the 1 month prior to Screening;
* Other protocol-specified exclusion criteria may apply.
C: Inclusion Criteria:

* All patients with meibomian gland dysfunction requiring treatment (defined below),
* who have given their written consent to the study.
* Meibomian gland dysfunction requiring treatment is classified by us as:
* Speed score\> 7, Lipiview \<61 nm, MGE \<5 of 15 open glands

Exclusion Criteria:

* Excluded are patients who, due to other diseases would not be able to fulfill the follow-up appointments or give an informed consent to the study
* Systemic medication with tetracyclin derivatives, antihistamines, isotretinoin, or nutritional supplements for MGD that started \<3 months before baseline examination
* Topical cyclosporine-A or steroids that started \<1 month before baseline examination
* Ocular surgery or trauma \<3 months before baseline examination
* Any eyelid abnormalities
* Systemic diseases resulting in dry eye.
D: Inclusion Criteria:

* Be between the ages of 18 and 79 years of age.
* Must understand and be able, willing and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

* Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia..
* Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for Dry Eye Disease, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
* Active ocular allergy.
* LASIK or PRK surgery that was performed within one year of Visit 1.
* Started or changed the dose of chronic ocular medication within 30 days of visit 1.
* Contact lens worn within the past eight (8) hours.
* Any ophthalmologic drops within 2 hours of screening and visit 1 procedures.
* Pregnancy or lactation.
* Abnormality of nasolacrimal drainage (by history).
* Punctual plugs placement or cauterization within 30 days of Visit 1
* Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Visit 1.
* Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days of Visit 1.
* Known hypersensitivity to any of the agents used in testing i.e. sodium fluorescein, lissamine green, oxybuprocaine or proparacaine.

Answer: C