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

Lumenis

Status: Completed

Conditions: Dry Eye; Dry Eye Syndromes; Skin Laxity; Eyelid Movement Disorders; Eyelid Diseases

Treatments: Device: TriLift device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05945069

LUM-VBU-TRILIFT-23-01

Details and patient eligibility

About

To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

TriLift

Experimental group

Description:

Combination of Dynamic Muscle Stimulation and Radiofrequency

Treatment:

Device: TriLift device