Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction

Jacksoneye

Status and phase: Completed; Phase 4

Conditions: Meibomian Gland Dysfunction

Treatments: Other: warm compress; Device: thermal pulsation

Study type: Interventional

Funder types: Other

Identifiers

NCT06326931

JE001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Thermal pulsation group

Experimental group

Description:

Group treated in both eyes with a single Systane iLux thermal pulsation treatment

Treatment:

Device: thermal pulsation

Warm compress group

Active Comparator group

Description:

Group treated in both eyes with 10 minute application of Bruder warm compress mask, twice daily for 8 weeks

Treatment:

Other: warm compress