Meibomian Gland Dysfunction Clinical Trial
Official title:
Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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