Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06220474

Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD

Led by The University of Hong Kong · Updated on 2026-04-27

112

Participants Needed

2

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this prospective, 24-week, double-masked, randomized, sham-controlled clinical trials to compare clinical efficacy and safety of RF and MGX with MGX alone in patients with meibomian gland dysfunction-related dry eye disease. The main question it aims to answer is whether radiofrequency treatment and meibomian gland expression is more effective in improving tear breakup time, as measured using non-invasive video keratography, compared with meibomian gland expression alone, in patients with refractory meibomian gland dysfunction-related dry eye disease. Participants will be divided into two groups, one group will receive RF treatment followed with MGX and another will receive sham treatment with MGX.

CONDITIONS

Official Title

Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Presence of dry eye symptoms and signs in both eyes confirmed by abnormal SPEED questionnaire score (≥5) and abnormal results in at least one clinical test (tear osmolarity, NIKBUT, or corneal staining)
  • Bilateral moderate to severe meibomian gland dysfunction with at least Grade 1 meibum quality (cloudy appearance) and Grade 2 meibum expressibility (moderate pressure required)
  • Refractory meibomian gland dysfunction defined as failure to respond to at least three types of conventional therapies (artificial tears, antibiotics, anti-inflammatory treatments, heat-based therapies) over at least 2 years
  • Fitzpatrick skin type I to IV
  • Mentally fit to provide informed consent
Not Eligible

You will not qualify if you...

  • Fitzpatrick skin type V or VI
  • History of eyelid scarring
  • Significant acinar gland atrophy (>30% dropout) seen on infrared meibography
  • Pregnancy or breastfeeding
  • Active corneal diseases such as infectious keratitis, allergic keratoconjunctivitis, pterygium, exposure keratopathy, lagophthalmos, trichiasis, or dellen
  • Current use of photosensitive systemic medications such as tetracycline antibiotics
  • History of corneal abnormality or surgery within the past 3 months

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Grantham Hospital

Hong Kong, Hong Kong

Actively Recruiting

2

HKU Eye Centre

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

K

Kendrick Co SHIH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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