Jacksoneye
Lake Villa, Illinois, 60046, United States
NCT Number: NCT06326931
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Lake Villa, Illinois, 60046, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single, in-office bilateral treatment with Systane iLux thermal pulsation
Other names: Systane iLux
Twice daily, 10-minute at-home treatment with Bruder warm compress mask for 8 weeks
Other names: Bruder mask
Time frame: baseline to Week 8
Change in MGS score for the worse eye
Time frame: baseline to Week 2
Change in MGS score for the worse eye
Time frame: Baseline to Week 2
Change in OSDI score
Time frame: Baseline to Week 8
Change in OSDI score
Time frame: 8 weeks
Incidence of adverse events
Jacksoneye
Other
A Prospective, Randomized Comparison of Thermal Pulsation Versus Warm Compress Treatment for Signs and Symptoms of Meibomian Gland Dysfunction
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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