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Lo studio clinico NCT06220474 per Sindrome dell'Occhio Secco, Disfunzione della Ghiandola di Meibomio è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD 112 Non invasivo Randomizzato

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06220474 è uno studio interventistico per Sindrome dell'Occhio Secco, Disfunzione della Ghiandola di Meibomio, attualmente in arruolamento. Avviato il 22 ottobre 2024, prevede di arruolare 112 partecipanti. Sotto la guida di l'Università di Hong Kong, dovrebbe concludersi entro il 31 dicembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 2 dicembre 2024.
Sommario breve
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...Mostra di più
Descrizione dettagliata
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 most populations , with a female preponderance. In the latest 2017 Tear Film and Ocular Surface Society Dry Eye Workshop II (TFOS DEWS II) Epidemiology Report, which compiled dry eye prevalence data from studies worldwide,...Mostra di più
Titolo ufficiale

Therapeutic Efficacy and Safety of Non-Invasive Radiofrequency Treatment in Patients With Refractory Meibomian Gland Dysfunction: A Randomized Controlled Trial

Patologie
Sindrome dell'Occhio SeccoDisfunzione della Ghiandola di Meibomio
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • 11221686
Numero NCT
NCT06220474
Data di inizio (effettiva)
2024-10-22
Ultimo aggiornamento pubblicato
2024-12-02
Data di completamento (stimata)
2027-12-31
Arruolamento (previsto)
112
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleRadiofrequency treatment (RF), followed by meibomian gland expression (MGX)
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...Mostra di più
The Thermage FLX System
The Thermage FLX System is tested for its therapeutic efficacy and safety on treating refractory Meibomian Gland Dysfunction
Comparatore simulatoSham treatment, followed by meibomian gland expression (MGX)
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.
Trattamento Simulato
Sham treatment acts as a control to test the therapeutic efficacy and safety of The Thermage FLX System
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Change in non-invasive keratographic tear breakup time (NIKBUT)
NIKBUT is measured in seconds and average of 3 consecutive readings is taken. Higher values mean better outcomes.
From baseline to 6 months post- treatment between study groups
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Change in Standard Patient Evaluation of Eye Dryness (SPEED) symptom score
One number was collected per patient, with higher scores meaning worse outcomes
From baseline to 6 months post-treatment between study groups
Percentage of subjects with normal non-invasive keratographic tear breakup time (NIKBUT)
\> 10 seconds, with lower scores meaning worse
6 months
Percentage of subjects with normal SPEED
\<5, with higher scores meaning worse
6 months
Change in best corrected visual acuity
from logmar(1.0 to -0.1)
from baseline to 6 months post-treatment
Incidence of periorbital pain
at least 3/10 and above, with higher scores meaning worse
6 months
Incidence of ocular adverse events
evidence of uveitis, conjunctivitis, scleritis/episcleritis, new lens opacities, new cornea opacities
6 months
Incidence of non-ocular adverse events
eyelid skin burn, eyelid redness, eyelid hyper/hypopigmentation
6 months
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  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

  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
The University of Hong Kong logoUniversità di Hong Kong335 studi clinici attivi da esplorare
Contatti principali dello studio
Contatto: Kendrick Co SHIH, 94326271, [email protected]
2 Centri dello studio in 1 paesi
Grantham Hospital, Hong Kong, Hong Kong
Kendrick Co Shih, Contatto
In arruolamento
HKU Eye Centre, Hong Kong, Hong Kong
Kendrick Co SHIH, Contatto, 94326271, [email protected]
In arruolamento