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

NCT03194698.

Trial name or title Efficacy of IPL treatment of dry eye and ocular rosacea
Methods Study design: randomised controlled trial
Study grouping: parallel group
Exclusions after randomisation? (If Yes, provide relevant details from the paper): not reported
Percentage of participant follow‐up (include details from all intervention groups): not reported
Study duration (of intervention): 4 months
Was a sample size calculation reported? (Yes/No): no
Participants Baseline characteristics
IPL group
  • Number of participants (number of eyes): not reported

  • Sex: not reported

  • Age: not reported


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

  • Sex: not reported

  • Age: not reported


Overall
  • Number of participants (number of eyes): estimated 20 (40)

  • Sex: not reported

  • Age: not reported


Inclusion criteria: dry eye of moderate severity with ocular rosacea diagnosed by ophthalmologist; dry eye symptoms must be alleviated with topical anaesthetic; must have ≥ 50% meibomian glands viable on meibography; contact lenses and refractive surgery are permitted; aged 18–100 years; either gender
Exclusion criteria: healthy volunteers; contraindications of severe ocular surface disease or inability to be safely treated with IPL; GVHD, Stevens‐Johnson syndrome, active allergic conjunctivitis or other conjunctivitis, alkali burn history; new treatments for dry eye in past 6 months
Significant pretreatment baseline differences? Not reported
Severity of dry eye: moderate
Interventions IPL
  • Description of the intervention: not reported

  • Duration of the intervention: treatment with 4 visits and 4 treatments over 4 months

  • Co‐interventions: MGX


Control
  • Description of the intervention: MGX only (no IPL)

  • Duration of the intervention: treatment with 4 visits and 4 treatments over 4 months

  • Co‐interventions: none

Outcomes Primary outcome:
  • OSDI survey at 4 months


Secondary outcomes:
  • pathological microbial load (analysis of RNA of ocular microbiome in tear samples)

  • TGF‐beta‐1 growth cytokine level (analysed from tear samples) at 4 months

Starting date 17 August 2017
Contact information Joanne F Shen
Department of Ophthalmology – Arizona, Mayo Clinic, Scottsdale, Arizona, US, 85259
Email: not reported
Telephone: not reported
Notes None