Back to resultsFeasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects With Dry Eye Disease
Primary Purpose
Eyelid Diseases, Eyelid Movement Disorders, Dry Eye
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TriLift device
Sponsored by
About this trial
This is an interventional treatment trial for Eyelid Diseases
Eligibility Criteria
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
Sites / Locations
- Manhattan Face and Eye Cosmetic and Orbital Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TriLift
Arm Description
Combination of Dynamic Muscle Stimulation and Radiofrequency
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05945069
Brief Title
Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects With Dry Eye Disease
Official Title
Feasibility of Dynamic Muscle Stimulation (DMSt) Combined With Radiofrequency (RF) for Improving Blink Quality in Subjects With Dry Eye Disease (DED)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 31, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumenis Be Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Diseases, Eyelid Movement Disorders, Dry Eye, Dry Eye Syndromes, Skin Laxity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TriLift
Arm Type
Experimental
Arm Description
Combination of Dynamic Muscle Stimulation and Radiofrequency
Intervention Type
Device
Intervention Name(s)
TriLift device
Intervention Description
Dynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids
Primary Outcome Measure Information:
Title
Impaired blink quality
Description
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.
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Other Pre-specified Outcome Measures:
Title
Eyelid appearance
Description
Biomicroscopy with the slit lamp; normal, mild, moderate, severe
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Title
Overall blink quality
Description
Subjectively assessed by the study investigator; normal, mildly impaired, moderately impaired, severely impaired
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Title
Margin to Reflex Distances MRD1 and MRD2
Description
Distances from the margins of the upper and lower lids to the central corneal reflex, in millimeters
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Title
modified Meibomian Gland Score
Description
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.
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Title
Ocular Surface Disease Index
Description
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.
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Title
Corneal sensitivity
Description
Measured with an esthesiometer; device settings: 1 to 6
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Title
Blink rate
Description
Blinks per minute during a video-watching task
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Title
Degree of eyelid closure
Description
full, or maximal vertical height of the palpebral fissure measured in mm
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Title
Teat Breakup time
Description
Time between full blink and first appearance of a break in a fluorescein-stained eye
Time Frame
7 weeks after baseline (4 weeks after the 4th treatment)
Title
Adverse events
Description
Incidence and type of adverse events
Time Frame
Throughout the study and up to 7 weeks after baseline (4 weeks after the 4th treatment)
Title
BCVA
Description
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)
Time Frame
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
Title
Pain/Discomfort
Description
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.
Time Frame
Immediately after a treatment session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Manor, Ph.D.
Phone
+972-52-376-3416
Email
yair.manor@lumenis.com
First Name & Middle Initial & Last Name or Official Title & Degree
James G Chelnis, MD
Phone
(+1) 212-484-9707
Email
drchelnis@manhattanfaceandeye.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G Chelnis, MD
Organizational Affiliation
Manhattan Face and Eye
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Face and Eye Cosmetic and Orbital Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Chelnis, MD
Phone
212-484-9707
Email
drchelnis@manhattanfaceandeye.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects With Dry Eye Disease
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