A randomized, sham-controlled trial of intraductal meibomian gland probing with or without topical antibiotic/steroid for obstructive meibomian gland dysfunction

Abstract

ImportanceObstructive meibomian gland dysfunction (MGD) can be refractory to medical therapy. Intraductal meibomian gland (MG) probing may offer a potential therapeutic approach for these patients, but no randomized trials have been conducted to date. ObjectiveTo assess clinical changes after intraductal MG probing for patients with refractory obstructive meibomian gland dysfunction. DesignRandomized, double-masked, sham-controlled clinical trial. SettingSingle-center, tertiary referral center. Participants42 patients with refractory obstructive MGD associated with lid tenderness. InterventionsEnrolled patients received one of the following treatments: 1) MG probing plus post-procedural topical sulfacetamide/prednisolone ointment (Blephamide®), 2) MG probing plus post-procedural lubricating ointment (GenTeal), or 3) sham probing plus GenTeal ointment. The probing was performed on the upper lids of both eyes. Main outcome measuresPrimary outcome measures were symptoms as measured by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE), as well as tear break-up time (TBUT). Secondary outcome measures were other clinical signs. Safety of the procedure was also evaluated by investigating the treatment-related adverse events. At baseline and 4 weeks after the procedure a masked observer evaluated the following outcome measures: symptom questionnaires, including OSDI and SANDE, upper lid tenderness, lid margin telangiectasia, corneal fluorescein staining, conjunctival lissamine green staining, TBUT, Schirmer's test, and meibomian glands yielding liquid secretion (MGYLS). ResultsCompared to baseline, the MG probing/Blephamide® group showed significant improvements in both OSDI and SANDE scores and the MG probing/GenTeal group demonstrated a significant improvement only in SANDE score. In contrast, the Sham/GenTeal group did not show any statistically significant changes in symptoms. There were no statistically significant changes in clinical signs in any group at the 4-week visit, except for improvement of lid tenderness in the sham probing group. ConclusionsMG probing/Blephamide® results in a significant improvement in symptoms in patients with refractory obstructive MGD without any significant effect on clinical signs. Larger studies are warranted to determine the efficacy of MG probing. Trial registrationClinicaltrials.gov(identifier NCT02256969, Filed on 08/13/2014)