Dunes Eye Consultants
Dakota Dunes, South Dakota, 57049, United States
NCT Number: NCT06542276
Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.
Interested in participating?
Request Info25 year–65 year
All sexes
Interventional
Not applicable
Dakota Dunes, South Dakota, 57049, United States
Prospective, non-randomized, interventional study. Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. All subjects underwent a vectored thermal pulsation treatment (LipiFlow). Patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment. Data collected included tear osmolarity, tear break up time (TBUT), tear meniscus height (TMH), meibomian gland function and patient-reported symptoms using the ocular surface disease index (OSDI) questionnaire. Following the 3-month visit, patients were given the option to resume topical immunomodulator therapy.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The LipiFlow® (Johnson & Johnson Vision, USA) Thermal Pulsation System, also known as vectored thermal pulsation, is a treatment that applies localized heat and pressure to the meibomian glands lining the eyelids. The device consists of a console connected to single-use, sterile devices applied to each eye known as activators. The activator includes an eye warmer with a large lens that gently sits on the conjunctiva of each eye. The activator cups the upper and lower eyelid and applies regulated, outward heat to the surface of the palpebral conjunctiva with an air bladder that intermittently provides directional, controlled massage of the eyelids to promote expression of the liquified contents.
Other names: Lipiflow
Time frame: 3 months
OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM
Dunes Eye Consultants
Other
Single Vectored Thermal Pulsation Treatment in Patients Using Topical Immunomodulators in the Management of Dry Eye Disease
Acronym: Reduce
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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