MGD-Meibomian Gland Dysfunction
Conditions
Brief summary
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
DEVICEThermal 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 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.
Sponsors
Johnson & Johnson
Dunes Eye Consultants
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study, known as the REDUCE study, was a prospective, non-randomized, single-site, non- comparative study that evaluated the efficacy of a single vectored thermal pulsation (VTP) treatment in patients who were currently being treated with topical immunomodulator agents. This study was conducted in compliance with the Declaration of Helsinski and was reviewed and approved by the WCG institutional review board (IRB). The study is registered in clinictrials.gov. All participants provided written informed consent.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects discontinuing Topical Immunomodulator use | 3 months | OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM |
Countries
United States
Outcome results
None listed