Can radio waves zap dry eye away? new trial tests device for stubborn cases
NCT ID NCT06220474
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests whether a non-invasive radiofrequency device (Thermage FLX) plus eyelid gland expression can improve tear film stability better than gland expression alone in people with dry eye that hasn't responded to standard treatments. About 112 adults with moderate to severe meibomian gland dysfunction will be randomly assigned to receive either active radiofrequency or a sham procedure, followed by gland expression. The main goal is to see if tear breakup time improves over 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiofrequency treatment (Thermage FLX System)
- What this could lead to
- If it works, this could offer a new non-invasive option to ease dry eye symptoms for people who haven't improved with standard care.
- What could go wrong
- This is a small, early-stage trial (112 people) testing a device, not a drug. The sham control means the real benefit may be modest, and results may not apply to all dry eye patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 or more 2. Bilateral dry eye disease as confirmed by presence of both symptoms and signs 2.1 Symptoms: Abnormal result on the Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) dry eye symptom questionnaire (≥5) 2.2 Signs: Abnormal result in at least one of the following three clinical tests - tear osmolarity, NIKBUT and corneal staining for punctate epithelial erosions and, 3. Bilateral moderate to severe meibomian gland dysfunction - at least Grade 1 meibum quality (cloudy appearance) and Grade 2 meibum expressibility (moderate pressure required). And, 4. Refractory MGD - The failure to respond to at least three types of conventional therapy, including artificial tears, topical or systemic antibiotics and anti-inflammatory treatments and the aforementioned heat-based therapies, over a period of at least 2 years 5. Fitzpatrick skin type I-IV - Type V and VI skinned subjects are excluded from the study due to the high risk of pain and focal hypopigmentation 6. Mentally fit to give informed consent Exclusion Criteria: 1. Fitzpatrick skin type V-VI 2. History of eyelid scarring 3. Infrared meibography evidence of significant acinar gland atrophy (dropout of \>30%) - these patients have been shown not to benefit from heat-based therapies due to end-stage disease 4. Pregnancy or lactation 5. Active corneal disease such as infectious keratitis, allergic keratoconjunctivitis, pterygium, exposure keratopathy, lagophthalmos, trichiasis or dellen 6. Current systemic intake of photosensitive medications, including tetracycline group of drugs. 7. History of corneal abnormality or surgery within 3 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Grantham Hospital
RECRUITINGHong Kong, Hong Kong
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HKU Eye Centre
RECRUITINGHong Kong, Hong Kong
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