Dry Eye Clinical Trial
Official title:
Feasibility of Dynamic Muscle Stimulation (DMSt) Combined With Radiofrequency (RF) for Improving Blink Quality in Subjects With Dry Eye Disease (DED)
To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease
Status | Recruiting |
Enrollment | 30 |
Est. completion date | February 15, 2024 |
Est. primary completion date | January 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Manhattan Face and Eye Cosmetic and Orbital Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Lumenis Be Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Eyelid appearance | Biomicroscopy with the slit lamp; normal, mild, moderate, severe | 7 weeks after baseline (4 weeks after the 4th treatment) | |
Other | Overall blink quality | Subjectively assessed by the study investigator; normal, mildly impaired, moderately impaired, severely impaired | 7 weeks after baseline (4 weeks after the 4th treatment) | |
Other | 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) | |
Other | 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) | |
Other | 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) | |
Other | Corneal sensitivity | Measured with an esthesiometer; device settings: 1 to 6 | 7 weeks after baseline (4 weeks after the 4th treatment) | |
Other | Blink rate | Blinks per minute during a video-watching task | 7 weeks after baseline (4 weeks after the 4th treatment) | |
Other | 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) | |
Other | 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) | |
Other | Adverse events | Incidence and type of adverse events | Throughout the study and up to 7 weeks after baseline (4 weeks after the 4th treatment) | |
Other | 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 | |
Other | 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 | |
Primary | 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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