BMJ open ophthalmology · 2026
Clinical efficacy of portable, cost-effective manual thermal pulsation for obstructive meibomian gland dysfunction and factors associated with therapeutic efficacy.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Cheng Xiaoqi, Huang Hangyu, Fan Zixin, Wang Heyun, Zheng Xiaochun, Dong Lina, Li Ming, Zhang Guoming, Mi Shengli
Аннотация
OBJECTIVE: To evaluate the efficacy and safety of portable, cost-effective manual thermal pulsation as a single therapy for meibomian gland dysfunction (MGD) and to compare the microbiota and lipid composition in subjects with different therapeutic efficacy.
METHODS AND ANALYSIS: In this single-centre, randomised, positive-controlled clinical trial, 84 subjects were randomly assigned (1:1) to receive a single treatment of manual (self-developed device) or automatic (Lipiflow) thermal pulsation and followed up for 4 weeks, 76 of which were finally analysed. Efficacy was evaluated by Δ Meibomian Gland Score (MGS) (Δ variable=parameter at follow-up-parameter at baseline), Δ non-invasive break-up time (NIBUT), Δ standard patient evaluation of eye dryness (SPEED), Δ Meibomian Gland Expressibility Score (MES) and Δ corneal fluorescein staining (CFS), with safety investigated. Subjects who underwent manual thermal pulsation were further divided into two subgroups based on whether ΔMGS ≥-2, meibum microbiome and lipid metabolomics in the subgroups were analysed.
RESULTS: ΔMGS, ΔNIBUT, ΔSPEED, ΔMES and ΔCFS were not significantly different between manual and automatic thermal pulsation groups in 4 weeks (both p>0.05), indicating non-inferior efficacy of manual thermal pulsation. No serious ocular or device-related adverse events were reported. A more complex meibum microorganism diversity and 46 differentially expressed lipids (such as triglycerides, diglycerides, ceramides and oxidised species) were identified in those with a relatively weak therapeutic efficacy.
CONCLUSIONS: Portable, cost-effective manual thermal pulsation demonstrated non-inferiority to automatic thermal pulsation for MGD during the 4-week follow-up period, with therapeutic efficacy associated with meibum micro-organism and lipid components.
METHODS AND ANALYSIS: In this single-centre, randomised, positive-controlled clinical trial, 84 subjects were randomly assigned (1:1) to receive a single treatment of manual (self-developed device) or automatic (Lipiflow) thermal pulsation and followed up for 4 weeks, 76 of which were finally analysed. Efficacy was evaluated by Δ Meibomian Gland Score (MGS) (Δ variable=parameter at follow-up-parameter at baseline), Δ non-invasive break-up time (NIBUT), Δ standard patient evaluation of eye dryness (SPEED), Δ Meibomian Gland Expressibility Score (MES) and Δ corneal fluorescein staining (CFS), with safety investigated. Subjects who underwent manual thermal pulsation were further divided into two subgroups based on whether ΔMGS ≥-2, meibum microbiome and lipid metabolomics in the subgroups were analysed.
RESULTS: ΔMGS, ΔNIBUT, ΔSPEED, ΔMES and ΔCFS were not significantly different between manual and automatic thermal pulsation groups in 4 weeks (both p>0.05), indicating non-inferior efficacy of manual thermal pulsation. No serious ocular or device-related adverse events were reported. A more complex meibum microorganism diversity and 46 differentially expressed lipids (such as triglycerides, diglycerides, ceramides and oxidised species) were identified in those with a relatively weak therapeutic efficacy.
CONCLUSIONS: Portable, cost-effective manual thermal pulsation demonstrated non-inferiority to automatic thermal pulsation for MGD during the 4-week follow-up period, with therapeutic efficacy associated with meibum micro-organism and lipid components.