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To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease
The purpose of the study is to demonstrate that a combination of DMSt and RF applied on the periocular skin below the lower eyelids improves eye blink quality in subjects with moderate to severe signs and symptoms of dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TriLift | Experimental | Combination of Dynamic Muscle Stimulation and Radiofrequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TriLift device | Device | Dynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impaired blink quality | 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. | 7 weeks after baseline (4 weeks after the 4th treatment) |
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| Measure | Description | Time Frame |
|---|---|---|
| Eyelid appearance | Biomicroscopy with the slit lamp; normal, mild, moderate, severe | 7 weeks after baseline (4 weeks after the 4th treatment) |
| Overall blink quality | Subjectively assessed by the study investigator; normal, mildly impaired, moderately impaired, severely impaired |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James G Chelnis, MD | Manhattan Face and Eye | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Face and Eye Cosmetic and Orbital Surgery | New York | New York | 10019 | United States |
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| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D015352 | Dry Eye Syndromes |
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
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| 7 weeks after baseline (4 weeks after the 4th treatment) |
| Margin to Reflex Distances MRD1 and MRD2 | Distances from the margins of the upper and lower lids to the central corneal reflex, in millimeters | 7 weeks after baseline (4 weeks after the 4th treatment) |
| modified Meibomian Gland Score | 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. | 7 weeks after baseline (4 weeks after the 4th treatment) |
| Ocular Surface Disease Index | 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. | 7 weeks after baseline (4 weeks after the 4th treatment) |
| Corneal sensitivity | Measured with an esthesiometer; device settings: 1 to 6 | 7 weeks after baseline (4 weeks after the 4th treatment) |
| Blink rate | Blinks per minute during a video-watching task | 7 weeks after baseline (4 weeks after the 4th treatment) |
| Degree of eyelid closure | full, or maximal vertical height of the palpebral fissure measured in mm | 7 weeks after baseline (4 weeks after the 4th treatment) |
| Teat Breakup time | Time between full blink and first appearance of a break in a fluorescein-stained eye | 7 weeks after baseline (4 weeks after the 4th treatment) |
| Adverse events | Incidence and type of adverse events | Throughout the study and up to 7 weeks after baseline (4 weeks after the 4th treatment) |
| BCVA | 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) | At baseline, at 1 week after baseline (immediately before the second treatment), at 2 weeks after baseline (immediately before the third treatment), at 3 weeks after baseline (immediately before the fourth treatment) and at 7 weeks after baseline |
| Pain/Discomfort | 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. | Immediately after a treatment session |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |