Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD (NCT06220474) | Clinical Trial Compass
RecruitingNot Applicable
Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD
Hong Kong112 participantsStarted 2024-10-22
Plain-language summary
The goal of this prospective, 24-week, double-masked, randomized, sham-controlled clinical trials to compare clinical efficacy and safety of RF and MGX with MGX alone in patients with meibomian gland dysfunction-related dry eye disease. The main question it aims to answer is whether radiofrequency treatment and meibomian gland expression is more effective in improving tear breakup time, as measured using non-invasive video keratography, compared with meibomian gland expression alone, in patients with refractory meibomian gland dysfunction-related dry eye disease.
Participants will be divided into two groups, one group will receive RF treatment followed with MGX and another will receive sham treatment with MGX.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 or more
✓. 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,
✓. Bilateral moderate to severe meibomian gland dysfunction - at least Grade 1 meibum quality (cloudy appearance) and Grade 2 meibum expressibility (moderate pressure required). And,
✓. 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
✓. 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
✓. Mentally fit to give informed consent
Exclusion criteria
✕. Fitzpatrick skin type V-VI
What they're measuring
1
Change in non-invasive keratographic tear breakup time (NIKBUT)
Timeframe: From baseline to 6 months post- treatment between study groups
✕. 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
✕. Pregnancy or lactation
✕. Active corneal disease such as infectious keratitis, allergic keratoconjunctivitis, pterygium, exposure keratopathy, lagophthalmos, trichiasis or dellen
✕. Current systemic intake of photosensitive medications, including tetracycline group of drugs.
✕. History of corneal abnormality or surgery within 3 months