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

Launched by THE UNIVERSITY OF HONG KONG · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people suffering from a condition called meibomian gland dysfunction (MGD), which can lead to dry eye symptoms. The researchers want to find out if using radiofrequency (RF) treatment along with a technique called meibomian gland expression (MGX) is more effective than just using MGX alone for improving eye comfort and tear quality. The trial will last for 24 weeks and will involve two groups of participants, with one group receiving the RF treatment and the other receiving a sham (placebo) treatment.

To participate in this study, you need to be at least 18 years old and have moderate to severe dry eye symptoms that have not improved despite trying at least three different treatments over the past two years. You also need to have signs of MGD confirmed by specific tests. It’s important to note that this trial is currently recruiting participants, and those with certain skin types or specific eye conditions might not be eligible. If you join, you can expect regular check-ups to monitor your eye health and comfort throughout the study.

Gender

ALL

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