[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533027":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":63,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiofrequency treatment (RF), followed by meibomian gland expression (MGX)","EXPERIMENTAL","Before treatment, a thermage return pad will be applied to subject's skin to help prevent electrical burns. The return pad is a rubber, non-active electrode that creates a return path for radiofrequency energy back to the thermage comfort pulse technology (CPT) system. The upper and lower lid of both eyes are marked with skin marking paper (Thermage ® Skin Marking Paper TK-3.00). Coupling fluid is then applied to the external surface of the upper and lower lids of both eyes. All subjects then receive 225 applications to each eye over the upper and lower eyelids. Immediately after treatment, meibomian gland expression will be performed on both upper and lower eyelids of each eye for both eyes of all subjects using meibum expression forceps. Pain is minimized during this procedure by topical application of 0.4% oxybuprocaine hydrochloride.",[13],"Device: The Thermage FLX System",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham treatment, followed by meibomian gland expression (MGX)","SHAM_COMPARATOR","The training mode is used in the Thermage FLX, which simulates treatment without dissipation of radiofrequency energy. Immediately after treatment, meibomian gland expression will be performed on both upper and lower eyelids of each eye for both eyes of all subjects using meibum expression forceps. Pain is minimized during this procedure by topical application of 0.4% oxybuprocaine hydrochloride.",[19],"Device: Sham treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","The Thermage FLX System","The Thermage FLX System is tested for its therapeutic efficacy and safety on treating refractory Meibomian Gland Dysfunction",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham treatment","Sham treatment acts as a control to test the therapeutic efficacy and safety of The Thermage FLX System",[15],[32],{"name":33,"affiliation":34,"role":35},"Kendrick Co SHIH","The University of Hong Kong, Grantham Hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","94326271","kcshih@hku.hk",[42,56],{"facility":43,"status":44,"city":45,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Grantham Hospital","RECRUITING","Hong Kong","HK",{"type":48,"coordinates":49},"Point",[50,51],114.17469,22.27832,{"lat":51,"lon":50},[54],{"name":55,"role":38,"phone":26,"phoneExt":26,"email":26},"Kendrick Co Shih",{"facility":57,"status":44,"city":45,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"HKU Eye Centre",{"type":48,"coordinates":59},[50,51],{"lat":51,"lon":50},[62],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100533027","therapeutic-efficacy-and-safety-of-non-invasive-rf-treatment-in-refractory-mgd-100533027",false,"NCT06220474","Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD","Therapeutic Efficacy and Safety of Non-Invasive Radiofrequency Treatment in Patients With Refractory Meibomian Gland Dysfunction: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 18 or more\n2. 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,\n3. Bilateral moderate to severe meibomian gland dysfunction - at least Grade 1 meibum quality (cloudy appearance) and Grade 2 meibum expressibility (moderate pressure required). And,\n4. 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\n5. 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\n6. Mentally fit to give informed consent\n\nExclusion Criteria:\n\n1. Fitzpatrick skin type V-VI\n2. History of eyelid scarring\n3. 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\n4. Pregnancy or lactation\n5. Active corneal disease such as infectious keratitis, allergic keratoconjunctivitis, pterygium, exposure keratopathy, lagophthalmos, trichiasis or dellen\n6. Current systemic intake of photosensitive medications, including tetracycline group of drugs.\n7. History of corneal abnormality or surgery within 3 months","ALL","18 Years",{"count":75,"type":76},112,"ESTIMATED","INTERVENTIONAL",[79],"NA","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.\n\nParticipants will be divided into two groups, one group will receive RF treatment followed with MGX and another will receive sham treatment with MGX.",[82,83],"Dry Eye Syndromes","Meibomian Gland Dysfunction","2026-04-24",{"date":86,"type":87},"2026-04-27","ACTUAL",{"date":89,"type":87},"2024-10-22",{"date":91,"type":76},"2027-12-31",{"name":5,"class":6},2]