Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subject… (NCT05945069) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects with Dry Eye Disease
United States30 participantsStarted 2023-08-01
Plain-language summary
To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Impaired blink quality
Timeframe: 7 weeks after baseline (4 weeks after the 4th treatment)