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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal pulsation group | Experimental | Group treated in both eyes with a single Systane iLux thermal pulsation treatment |
|
| Warm compress group | Active Comparator | Group treated in both eyes with 10 minute application of Bruder warm compress mask, twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thermal pulsation | Device | Single, in-office bilateral treatment with Systane iLux thermal pulsation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in MGS score for the worse eye | Change in MGS score for the worse eye | baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MGS score for the worse eye | Change in MGS score for the worse eye | baseline to Week 2 |
| Change in OSDI score | Change in OSDI score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Bollinger, OD, FAAO | Jacksoneye | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksoneye | Lake Villa | Illinois | 60046 | United States |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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Prospective, randomized, controlled clinical trial
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The clinician evaluating MGS score was masked to subject treatment assignment
| warm compress | Other | Twice daily, 10-minute at-home treatment with Bruder warm compress mask for 8 weeks |
|
|
| Baseline to Week 2 |
| Change in OSDI score | Change in OSDI score | Baseline to Week 8 |
| Incidence of adverse events | Incidence of adverse events | 8 weeks |