The epidemiology of dry eye in Melbourne, Australia.
C A McCarty, A K Bansal, P M Livingston...
https://pubmed.ncbi.nlm.nih.gov/9627665Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06220474
Therapeutic Efficacy and Safety of Non-Invasive Radiofrequency Treatment in Patients With Refractory Meibomian Gland Dysfunction: A Randomized Controlled Trial
Led by The University of Hong Kong · Updated on 2026-04-27
112
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of radiofrequency (RF) treatment combined with meibomian gland expression (MGX) compared to MGX alone in patients with refractory meibomian gland dysfunction (MGD)-related dry eye disease. This 24-week randomized, double-masked, sham-controlled clinical trial aims to determine if RF treatment improves tear breakup time, a key measure of eye surface stability, in patients who have not responded to conventional therapies over at least two years. Participants will be assigned to one of two groups: one receiving the Thermage FLX System RF treatment followed by MGX, and the other receiving a sham treatment followed by MGX. The RF treatment involves applying controlled radiofrequency energy to the upper and lower eyelids and the tragus area to target meibomian glands, followed immediately by meibum expression using forceps with topical pain relief. The sham group undergoes a simulated treatment without radiofrequency energy, also followed by MGX. During the study, participants will have assessments including non-invasive keratographic tear breakup time (NIKBUT), symptom questionnaires, visual acuity tests, and monitoring for eye-related and other adverse events. The main outcome measured is the change in tear breakup time from baseline to six months post-treatment. Safety and symptom scores will also be evaluated. Participants will be followed for six months, with all treatments and evaluations conducted under medical supervision.
CONDITIONS
Brief Title
Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 or more
- Bilateral dry eye disease confirmed by symptoms and clinical signs
- Abnormal Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score of 5 or more
- Abnormal result in at least one clinical test: tear osmolarity, non-invasive keratographic tear breakup time (NIKBUT), or corneal staining
- Bilateral moderate to severe meibomian gland dysfunction with at least Grade 1 meibum quality and Grade 2 meibum expressibility
- Refractory meibomian gland dysfunction with failure to respond to at least three types of conventional therapy including artificial tears, antibiotics, anti-inflammatory treatments, and heat-based therapies over at least 2 years
- Fitzpatrick skin type I to IV
- Mentally fit to give informed consent
You will not qualify if you...
- Fitzpatrick skin type V or VI
- History of eyelid scarring
- Significant acinar gland atrophy (>30%) shown by infrared meibography
- Pregnancy or lactation
- Active corneal disease such as infectious keratitis, allergic keratoconjunctivitis, pterygium, exposure keratopathy, lagophthalmos, trichiasis, or dellen
- Current use of photosensitive medications including tetracycline group drugs
- History of corneal abnormality or surgery within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment visit
Participants receive either the Thermage FLX System radiofrequency treatment or a sham treatment, followed by meibomian gland expression on both eyes to treat refractory Meibomian Gland Dysfunction.
1 treatment visit (in-person)
Follow-up
Duration - 6 months
Participants are monitored for safety and efficacy outcomes including tear breakup time, symptom scores, and adverse events for up to 6 months after treatment.
Multiple visits over 6 months for assessments
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
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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