Dry Eye, Dry Eye Syndromes, Eyelid Diseases, Eyelid Movement Disorders, Skin Laxity
Conditions
Brief summary
To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease
Detailed description
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.
Interventions
DEVICETriLift device
Dynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids
Sponsors
Lumenis Be Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is able to read, understand and sign an Informed Consent Form (ICF) * 22 or older * Lower lid laxity, as clinically judged with lower lid DT and the snapback test * Moderate to severe OSDI (larger or equal to 23) * TBUT smaller or equal to 5 sec in both eyes
Exclusion criteria
* Abnormally high blink rate, as estimated by the study investigator * Any ocular surgery or eyelid surgery, within 3 months prior to screening * Blepharoptosis * Moderate or Severe Floppy Lid Syndrome * Corneal Dystrophy * Exophthalmos * Thyroid Eye Disease * Ocular Chemical Injury or burn * Limbal Stem Cell Deficiency * Facial Nerve Palsy * Blepharospasm * Hemifacial Spasm * Corneal neuropathy * Pregnant or nursing women * Participation in a different study * Any condition revealed whereby the study investigator deems the subject inappropriate for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impaired blink quality | 7 weeks after baseline (4 weeks after the 4th treatment) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall blink quality | 7 weeks after baseline (4 weeks after the 4th treatment) | Subjectively assessed by the study investigator; normal, mildly impaired, moderately impaired, severely impaired |
| Margin to Reflex Distances MRD1 and MRD2 | 7 weeks after baseline (4 weeks after the 4th treatment) | Distances from the margins of the upper and lower lids to the central corneal reflex, in millimeters |
| modified Meibomian Gland Score | 7 weeks after baseline (4 weeks after the 4th treatment) | 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. |
| Ocular Surface Disease Index | 7 weeks after baseline (4 weeks after the 4th treatment) | 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. |
| Corneal sensitivity | 7 weeks after baseline (4 weeks after the 4th treatment) | Measured with an esthesiometer; device settings: 1 to 6 |
| Eyelid appearance | 7 weeks after baseline (4 weeks after the 4th treatment) | Biomicroscopy with the slit lamp; normal, mild, moderate, severe |
| Degree of eyelid closure | 7 weeks after baseline (4 weeks after the 4th treatment) | full, or maximal vertical height of the palpebral fissure measured in mm |
| Teat Breakup time | 7 weeks after baseline (4 weeks after the 4th treatment) | Time between full blink and first appearance of a break in a fluorescein-stained eye |
| Adverse events | Throughout the study and up to 7 weeks after baseline (4 weeks after the 4th treatment) | Incidence and type of adverse events |
| BCVA | 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 | 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 | Immediately after a treatment session | 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. |
| Blink rate | 7 weeks after baseline (4 weeks after the 4th treatment) | Blinks per minute during a video-watching task |
Countries
United States
Outcome results
None listed