Intraductal Meibomian Gland Probing Trial

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph B. Ciolino, MD; Massachusetts Eye and Ear Infirmary
• Treatments: Anesthetics; Lidocaine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Mineral Oil; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sulfacetamide

Criteria

Inclusion Criteria:

• Age 18-89 years

• Willing and able to provide written informed consent

• Willing and able to comply with study assessments for the full duration of the study

• Diagnosis of meibomian gland dysfunction (MGD)

• Symptoms of MGD such as foreign body sensation, burning, stinging, light sensitivity for at least 3 months

• Persistent symptoms despite at least 3 months of medical management including lid hygiene, warm compress, and use of topical and systemic therapy, or contraindication to systemic therapy

• Presence of lid tenderness on the upper lids in both eyes

• Tear break-up time (TBUT) of <10 seconds

• In good stable overall health

Exclusion Criteria:

• Active allergies to steroids, sulfacetamide, GenTeal PM Night-Time ointment, or lidocaine

• Intraocular surgery or ocular laser surgery within 1 month before enrollment

• History of ocular infection within 1 month before enrollment.

• History of increased intraocular pressure after using topical steroids (steroid responsive)

• Any condition (including language barrier) that precludes subject's ability to comply with study requirements including completion of study