Intraductal Meibomian Gland Probing Trial
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      In this research study, the investigators are looking at the effects of Meibomian Gland
      Probing (MGP) versus a sham (fake) procedure in patients with refractory MGD who have already
      tried traditional management with no success in resolving their clinical signs (as seen by
      their ophthalmologist) or their symptoms.

      The investigators are also evaluating the effects of using two (2) post-procedural medication
      treatments: Blephamide or GenTeal PM Night-Time to determine if treatment after the MGP
      procedure has an effect on its outcome.
    

Detailed description: 
      Dry eye disease is one of the most common conditions seen in ophthalmic practice and is
      associated with significant patient distress. Meibomian gland dysfunction (MGD) is among the
      most prevalent causes of dry eye disease. This condition, which is often due to obstruction
      of the meibomian gland orifices, may result in significant ocular irritation. Traditionally,
      management of MGD includes warm compress, lid hygiene, and anti-inflammatory medications.
      This randomized clinical trial is designed to evaluate the effects of meibomian gland probing
      versus sham procedure in cases with refractory MGD that do not respond to traditional
      treatments. Moreover, the effects of postoperative regimen will also be investigated using
      two different regimens. In addition to symptoms, the changes will also be evaluated in terms
      of clinical signs as well as in vivo confocal microscopy (IVCM) which allows study at the
      cellular level.
    

Intervention name(s): Blephamide; GenTeal PM Night-Time; Meibomian Gland Probing; Sham Meibomian Gland Probing
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention description(s): For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. After obtaining adequate anesthesia, the solid stainless steel probes (Maskin® Meibomian Gland Intraductal Probes, Rhein Medical Inc.) were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were initially be probed with a 1-mm probe followed by a 2-mm probe for all glands.; For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. The patient's lid margin was touched with the probes without actual probing of the meibomian gland orifices.
Other intervention name(s): sulfacetamide sodium 10%/prednisolone acetate 0.2%, Allergan, Inc.; GenTeal PM Night-Time Ophthalmic Ointment Alcon
Intervention MeSH terms: Sulfacetamide; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Mineral Oil; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment