Non-invasive radiofrequency treatment for dry eye disease

Therapeutic Efficacy and Safety of Non-Invasive Radiofrequency Treatment in Patients With Refractory Meibomian Gland Dysfunction: A Randomized Controlled Trial

This study is testing if a new non-invasive radiofrequency treatment combined with a special eye massage can help people with stubborn dry eye feel better compared to just the massage alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Hong Kong (other)
• Locations: 2 sites (Hong Kong and 1 other locations)
• Trial ID: NCT06220474 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of non-invasive radiofrequency (RF) treatment combined with meibomian gland expression (MGX) in patients suffering from refractory meibomian gland dysfunction-related dry eye disease. Participants will be randomly assigned to receive either the RF treatment followed by MGX or a sham treatment with MGX alone. The study will measure improvements in tear breakup time using non-invasive video keratography over a 24-week period. The goal is to determine if the combination treatment is more effective than MGX alone in alleviating symptoms of dry eye disease.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with moderate to severe meibomian gland dysfunction and refractory dry eye symptoms.

Not a fit: Patients with skin types V and VI may not benefit from this study due to a higher risk of complications.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from refractory dry eye disease.

How similar studies have performed: While there have been studies on various treatments for dry eye disease, the specific combination of RF treatment with MGX is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Hong Kong and 1 other locations

• Grantham Hospital — Hong Kong, Hong Kong (RECRUITING)
• HKU Eye Centre — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Kendrick Co SHIH — The University of Hong Kong, Grantham Hospital
• Study coordinator: Kendrick Co SHIH

Conditions: Dry Eye Syndromes, Meibomian Gland Dysfunction