Status:
RECRUITING
Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD
Lead Sponsor:
The University of Hong Kong
Conditions:
Dry Eye Syndromes
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Dry eye disease(DED) is a prevalent age-related ophthalmic condition. Depending on the population studied and the diagnostic criteria used, dry eye disease is estimated to have a high prevalence in mo...
Eligibility Criteria
Inclusion
- 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
- Fitzpatrick skin type V-VI
- History of eyelid scarring
- 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
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06220474
Start Date
October 22 2024
End Date
December 31 2027
Last Update
December 2 2024
Active Locations (2)
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1
Grantham Hospital
Hong Kong, Hong Kong
2
HKU Eye Centre
Hong Kong, Hong Kong