Non-invasive radiofrequency treatment for dry eye disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Grantham Hospital
  Hong Kong, 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
• Email: kcshih@hku.hk
• Phone: 94326271

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.