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. 2020 Mar 18;2020(3):CD013559. doi: 10.1002/14651858.CD013559

ChiCTR‐INR‐16009781.

Trial name or title The clinical application and significance of ocular surface function and tear lipid layer examination
Methods Study design: randomised controlled trial
Study grouping: parallel group
Exclusions after randomisation? Not reported
Percentage of participant follow‐up: not applicable
Study duration (of intervention): not reported
Was a sample size calculation reported: not reported
Participants Baseline characteristics
Standard therapy group
  • Number of participants (number of eyes): 25 (not reported)

  • Sex: not reported

  • Age: not reported


IPL group
  • Number of participants (number of eyes): 25 (not reported)

  • Sex: not reported

  • Age: not reported


LipiFlow
  • Number of participants (number of eyes): 25 (not reported)

  • Sex: not reported

  • Age: not reported


Overall
  • Number of participants (number of eyes): 75 (not reported)

  • Sex: not reported

  • Age: not reported


Inclusion criteria: aged 18–80 years; willing to follow study protocol; diagnosed with MGD; SPEED score ≥ 6; meibomian gland secretion score ≤ 12 for 15 glands of the lower lid; complete informed consent.
Exclusion criteria: pregnant or breastfeeding woman; SPEED score ≥ 15; meibomian gland dropout area of any lower lid ≥ 50%; any co‐existing ocular conditions that could interfere with dry eye (e.g. use of systemic antihistamines, anti‐inflammatory drugs or corticosteroids); any co‐existing ocular conditions that could interfere with treatment (e.g. Fitzpatrick skin type VI).
Significant pretreatment baseline differences? Not reported
Severity of dry eye: not reported
Interventions Standard therapy
  • Description: warming eye mask

  • Duration: not reported

  • Co‐interventions: not reported


IPL
  • Description: IPL

  • Duration: not reported

  • Co‐interventions: not reported


LipiFlow
  • Description: LipiFlow

  • Duration: not reported

  • Co‐interventions: not reported

Outcomes Primary outcomes:
  • OSDI

  • SPEED

  • BUT

  • LLT


Secondary outcome:
  • TMH


(Time points not reported in clinical trial registry)
Starting date Not yet recruiting (as of 18 September 2019)
Contact information Study leader:
Billian Ke
100 Haining Road, Hongkou District, Shanghai, China
Email: kebilian@126.com
Telephone: +86 13386259873
Notes None