Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thermal Vectored Pulsation.
- Who it may be relevant to
- Registry conditions: MGD-Meibomian Gland Dysfunction. Basic parameters: 25 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Single Vectored Thermal Pulsation Treatment in Patients Using Topical Immunomodulators in the Management of Dry Eye Disease
Overview
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.
Detailed description
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.
Interventions
- Device Thermal Vectored Pulsation
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 regulate
Primary outcome measures
- Number of Subjects discontinuing Topical Immunomodulator use [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- No prior history of meibomian gland treatment procedures LipiFlow, TearCare, or I-Lux
- lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years
- Meibograpy documneted retention of at least 50% of meibomian glands.
Exclusion criteria
- evidence of meibomian gland dropout exceeding 50%
- ocular rosacea,
- ocular surgery within the preceding three months
- prior in-office thermal meibomian gland treatment
- ocular trauma within preceding three months
- ocular herpetic infection
- chronic or recurrent inflammation
- eyelid abnormalities affecting lid function ocular surface abnormalities compromising corneal integrity (eg, epithelial basement membrane dystrophy, corneal burn)
- pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Dunes Eye Consultants — Dakota Dunes
Identifiers
NCT: NCT06542276 · DunesEye