Meibomian Gland Dysfunction
Conditions
Brief summary
This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks.
Detailed description
This prospective, single-center, single-masked, randomized, controlled clinical trial compared the Systane iLux handheld thermal pulsation system with a warm compress mask (Bruder Moist Heat Eye Compress, Bruder Healthcare, Alpharetta, GA, USA) for the treatment of meibomian gland dysfunction (MGD). Subjects aged 18 or older were randomized 1:1 to either a single in-office thermal pulsation treatment or twice-daily use of the warm compress mask, with both eyes undergoing the same treatment. Enrollment criteria included Ocular Surface Disease Index (OSDI) score \>23, total meibomian gland secretion (MGS) score \< or =12 in the lower lid of each eye, and tear break-up time (TBUT) \< 10 seconds. TBUT, MGS, and corneal staining scores were evaluated at baseline, 2 weeks, and 8 weeks. Symptoms were evaluated using the OSDI questionnaire at baseline, 2 weeks, and 8 weeks.
Interventions
DEVICEthermal pulsation
Single, in-office bilateral treatment with Systane iLux thermal pulsation
OTHERwarm compress
Twice daily, 10-minute at-home treatment with Bruder warm compress mask for 8 weeks
Sponsors
Jacksoneye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinician evaluating MGS score was masked to subject treatment assignment
Intervention model description
Prospective, randomized, controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* history of self-reported dry eye symptoms for 3 months prior to study enrollment * baseline OSDI score of 23 or greater ( * MGS score of 12 ior less in the lower eyelid of each eye * TBUT \<10 seconds * willing and able to abstain from using any new ocular lubricants
Exclusion criteria
* diagnosis of thyroid dysfunction or rheumatoid arthritis * history of laser-assisted in situ keratomileusis (LASIK); any other ocular surgery within the previous 12 months * abnormal lid anatomy or active lid lesions * use of topical glaucoma medications, medications affecting the central nervous system, or hormonal drugs within the previous month * active ocular infection * pterygium * planned use of contact lenses, topical antibiotics, steroids, or immunomodulating drops * CDVA worse than 0.2 logMAR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MGS score for the worse eye | baseline to Week 8 | Change in MGS score for the worse eye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in MGS score for the worse eye | baseline to Week 2 | Change in MGS score for the worse eye |
| Change in OSDI score | Baseline to Week 2 | Change in OSDI score |
| Incidence of adverse events | 8 weeks | Incidence of adverse events |
Countries
United States
Outcome results
None listed