{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Tsinghua Shenzhen International Graduate School, Shenzhen, China"
      ],
      "name": "Xiaoqi Cheng"
    },
    {
      "affiliations": [
        "Shenzhen Eye Hospital, Shenzhen Eye Medical Center, Southern Medical University, Shenzhen, China",
        "Shenzhen School of Clinical Medicine, Southern Medical University, Shenzhen, China"
      ],
      "name": "Hangyu Huang"
    },
    {
      "affiliations": [
        "Shenzhen Eye Hospital, Shenzhen Eye Medical Center, Southern Medical University, Shenzhen, China"
      ],
      "name": "Zixin Fan"
    },
    {
      "affiliations": [
        "Research Institute of Tsinghua University, Shenzhen, China"
      ],
      "name": "Heyun Wang"
    },
    {
      "affiliations": [
        "Research Institute of Tsinghua University, Shenzhen, China"
      ],
      "name": "Xiaochun Zheng"
    },
    {
      "affiliations": [
        "Tsinghua Shenzhen International Graduate School, Shenzhen, China"
      ],
      "name": "Lina Dong"
    },
    {
      "affiliations": [
        "Shenzhen Eye Hospital, Shenzhen Eye Medical Center, Southern Medical University, Shenzhen, China"
      ],
      "name": "Ming Li"
    },
    {
      "affiliations": [
        "Shenzhen Eye Hospital, Shenzhen Eye Medical Center, Southern Medical University, Shenzhen, China"
      ],
      "name": "Guoming Zhang"
    },
    {
      "affiliations": [
        "Tsinghua Shenzhen International Graduate School, Shenzhen, China"
      ],
      "name": "Shengli Mi"
    }
  ],
  "title": "Clinical efficacy of portable, cost-effective manual thermal pulsation for obstructive meibomian gland dysfunction and factors associated with therapeutic efficacy",
  "uid": "d79b5b52-47ff-5ff3-9a87-5013ddb54133"
}