NCT06220474 Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD
| NCT ID | NCT06220474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Dry Eye Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2024-10-22 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Kendrick Co SHIH
PRINCIPAL INVESTIGATOR
The University of Hong Kong, Grantham Hospital
Frequently Asked Questions
Who can join the NCT06220474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06220474 currently recruiting?
Yes, NCT06220474 is actively recruiting participants. Contact the research team at kcshih@hku.hk for enrollment information.
Where is the NCT06220474 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Hong Kong, Hong Kong.
Who is sponsoring the NCT06220474 clinical trial?
NCT06220474 is sponsored by The University of Hong Kong. The principal investigator is Kendrick Co SHIH at The University of Hong Kong, Grantham Hospital. The trial plans to enroll 112 participants.