Trial reportBMJ open ophthalmology2026
Clinical efficacy of portable, cost-effective manual thermal pulsation for obstructive meibomian gland dysfunction and factors associated with therapeutic efficacy.
Trial report in BMJ open ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
9 authors.
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Abstract
objectiveTo 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.
resultsΔMGS, 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.
conclusionsPortable, 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.
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