Dynamic Muscle Stimulation of the Periorbital Area for Improvement of Blinking in Dry Eye Patients

To investigate whether Dynamic Muscle Stimulation technology (DMSt) in the peri-orbital area improves blinking quality in subjects with lower lid laxity and dry eye disease (DED) due to Meibomian Gland Dysfunction (MGD).

Eligible subjects had lower lid laxity and DED due to MGD. Treatment consisted of DMSt administered 4 times at 1-week intervals. Outcome measures were tested before each treatment and at the follow-up (FU) 4 weeks after the final treatment. The main hypothesis was a decrease in the proportion of subjects with lower lid laxity, defined as abnormal lower lid distraction test (LLDT) or abnormal snap-back test (SBT). Outcomes related to DED comprised the modified meibomian gland score (mMGS), tear breakup time (TBUT), and symptoms of DED (OSDI). Other outcomes included the Margin to Reflex Distance 1 and 2 (MRD1 and MRD2), estimation of blink rate, blink quality, and eyelid appearance.

30 subjects completed FU. LLDT decreased from 11.1 (SD 2.2) mm to 5.3 (SD 1.3) mm (P<0.0001). The proportion of subjects with normal LLDT and SBT increased from 3% to 80% and from 30% to 93%, respectively (p<0.0001). Lower lid laxity decreased from 100% at BL to 23% at FU (p<0.0001). MRD2 gradually decreased from 5.5 (SD 0.9) mm at BL to 5.0 (SD 0.4) mm at FU (P<0.001). TBUT, mMGS, and OSDI changed by +286%, -78%, and -53%, respectively (P<0.0001). The proportion of subjects with normal eyelid appearance, blink quality, blink rate and eyelid closure increased from 0 to 63% (p<0.0001), 0 to 73% (p<0.0001), 36% to 93% (p<0.0001) and 73% to 100% (p<0.01), respectively. No adverse events occurred.

In DED patients, DMSt in the peri-orbital area decreases lower lid laxity and improves blinking quality. These, in turn, may be useful for managing signs and symptoms of DED due to MGD.