Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects with Dry Eye Disease

binary (yes/no) variable, based on clinical estimation of the study investigator who will use a combination of two complementary tests (the lower lid distraction test and the snap-back test) to reach a yes/no decision.

Biomicroscopy with the slit lamp; normal, mild, moderate, severe

Subjectively assessed by the study investigator; normal, mildly impaired, moderately impaired, severely impaired

Distances from the margins of the upper and lower lids to the central corneal reflex, in millimeters

15 meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2 = inspissated meibum; 3 = blocked). The modified Meibomian Gland score will be evaluated as the sum of scores for these 15 glands. Hence, the minimal value is 0 (all 15 glands express a clear liquid meibum), and the maximal value is 45 (all 15 glands are blocked). A decrease in the modiified Meibomian Gland Score means that the functionality of meibomian glands improved, and that the condition of the patient improved.

Symptoms will be self-evaluated with the Ocular Surface Disease Index questionnaire. Twelve (12) questions will be asked about visual difficulties experienced by the subject during the past week. Each question will be scored 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time) or 4 (all the time). The Ocular Surface Disease Index will be calculated as the sum of scores times 25, divided by the number of questions answered. An increase in the Ocular Surface Disease Index means that the symptoms are reduced and that the condition of the patient improved.

Measured with an esthesiometer; device settings: 1 to 6

Blinks per minute during a video-watching task

full, or maximal vertical height of the palpebral fissure measured in mm

Time between full blink and first appearance of a break in a fluorescein-stained eye

Incidence and type of adverse events

Best-corrected visual acuity, using an ETDRS chart (20/20, 20/25, 20/32,20/40,20/50,20/63, 20/80, 20/100, 20/200, 20/400, where 20/20 is considered perfect vision and 20/400 is considered legal blindness)

Pain.discomfort will be self-reported with a visual analog scale (0 to 100), with 0 representing no pain/discomfort and 100 representing intolerable pain/discomfort. A decrease in this visual analog score represents an improvement in the perception of pain/discomfort.