Comparative Effects of USB-Powered Warm Compress and Self-Heating Eye Mask in the Management of Meibomian Gland Dysfunction
USB-Powered vs. Self-Heating Warm Compresses for Meibomian Gland Dysfunction: A Prospective Randomized Crossover Trial
Why was this study done?
People with Meibomian Gland Dysfunction (MGD) often have dry, irritated eyes because the tiny oil glands in their eyelids do not work properly. Applying gentle heat to the eyelids is a common way to improve the flow of oil and relieve symptoms.
This study wanted to find out whether a USB-powered warm compress or a self-heating disposable eye mask works better and feels more comfortable for patients with MGD.
Who took part?
Adults diagnosed with Meibomian Gland Dysfunction were invited to participate. Each person tried both treatments, one after the other, with a short break between them (this is called a crossover design).
What did participants do?
In one treatment phase, participants used a USB-powered warm compress for about 10 minutes per day over two weeks.
In the other phase, they used a self-heating disposable eye mask for the same amount of time.
The order of treatments was randomized to avoid bias.
Before and after each treatment, eye tests and comfort questionnaires were completed.
What did the study measure?
The main goal was to see if the treatments improved:
Tear film stability (how long the tears stay on the eye surface)
Meibomian gland function (how well the glands release oil)
Eye comfort and dryness symptoms
What were the results?
Both the USB-powered warm compress and the self-heating eye mask helped improve tear stability and comfort.
However, the USB-powered device provided slightly better results in improving gland function and patient satisfaction.
No serious side effects or discomfort were reported.
What do these results mean?
Regular eyelid warming is an effective way to manage MGD and dry eye symptoms. Both devices are safe and easy to use, but a USB-powered warm compress may offer stronger and more consistent heat for better results.
Patients and eye-care professionals can choose the device that best fits daily routines, comfort, and lifestyle.
Who conducted the study?
The study was carried out by optometrists and vision scientists specializing in ocular surface disease and dry eye therapy.
It followed ethical approval and was reviewed by an institutional research board before beginning.
Why is this study important?
MGD is one of the most common causes of dry eye disease worldwide. Understanding which home-based treatment works best helps patients, families, and clinicians make informed choices about safe and effective care options.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Meibomian gland dysfunction (MGD) is a leading cause of evaporative dry eye, characterized by obstruction and altered secretion of the meibomian glands that results in tear film instability and ocular discomfort. Thermal therapy is considered a cornerstone in the management of MGD, as controlled eyelid warming can enhance lipid flow, reduce stagnation, and restore tear film quality. However, the effectiveness and convenience of commercially available warming devices may vary depending on their design and heat delivery mechanisms.
This randomized, prospective, crossover clinical trial was designed to compare the efficacy and user experience of two commonly used warming modalities: a USB-powered eyelid warming device and a disposable self-heating eye mask. Each participant received both interventions in separate treatment phases, with a washout period in between, to minimize inter-subject variability. The order of intervention was randomized, ensuring balanced exposure across participants.
The study primarily aimed to assess changes in tear film stability and meibomian gland function following each treatment. Additional measures included ocular surface comfort, tear meniscus height, and patient preference. Standardized clinical assessments were conducted before and after each intervention phase, and validated questionnaires were used to capture subjective symptoms and usability feedback. Safety and tolerability were monitored throughout all sessions.
This investigation sought to generate comparative data on the short-term outcomes of two practical home-based treatment methods for MGD. The crossover design provided the advantage of within-subject comparison, enhancing the precision of treatment effect estimates. The findings are expected to inform clinicians about device selection for eyelid warming therapy and contribute to patient-centered recommendations in dry eye and ocular surface management.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Central Region
-
Riyadh, Central Region, Arabia Saudita, RIAYDH 113
- King Saud University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adults aged 18-40 years diagnosed with Meibomian Gland Dysfunction (MGD).
Baseline NITBUT < 10 seconds.
Willing to discontinue other lid therapies during the study period.
Exclusion Criteria:
- Active ocular infection or inflammation.
Recent ocular surgery (<3 months).
Use of contact lenses during the study period.
Systemic diseases affecting tear film (e.g., Sjögren's syndrome).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: USB-Powered Warm Compress
Will use A USB-Powered Warm Compress constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks
|
A constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks.
Altri nomi:
A disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks.
|
|
Sperimentale: Disposable eye mask
The group will use A disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks
|
A constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks.
Altri nomi:
A disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tear Meniscus Height
Lasso di tempo: Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
|
To assess the tear film.
The test was performed before and after each treatment phase to determine the improvement in tear film integrity following the application of each eyelid warming device.
|
Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
|
|
Ocular Surface Disease Index
Lasso di tempo: Baseline
|
he OSDI, which was created by the Outcomes Research Group at Allergan Inc in order to quickly assess the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision.[5] This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life.[6] The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.[7] The OSDI assesses quality of life measures, which aligns the questionnaire with Federal Food and Drug Administration's emphasis on utilizing patient-reported |
Baseline
|
|
tear break-up time
Lasso di tempo: Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
|
Non-Invasive Tear Break-Up Time (NITBUT) to assess the stability and uniformity of the tear film.
The test was performed before and after each treatment phase to determine the improvement in tear film integrity following the application of each eyelid warming device.
|
Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
|
|
Standard Patient Evaluation of Eye Dryness
Lasso di tempo: Baseline at Day 1 and post intervention at Day 5.
|
The SPEED questionnaire was designed by Korb and Blackie in order to quickly track the progression of dry eye symptoms over time.[9]
This questionnaire gives a score from 0 to 28 that is the result of 8 items that assess frequency and severity of symptoms.
The symptoms assessed include dryness, grittiness, scratchiness, irritation, burning, watering, soreness, and eye fatigue.
The questionnaire further assesses whether these symptoms were not problematic, tolerable, uncomfortable, bothersome, or intolerable.[10]
The questionnaire also monitored diurnal and symptoms changes over 3 months.[11]
Validity of the questionnaire was determined by seeing how well it was able to segregate patients based on their symptoms, relative to the OSDI questionnaire (gold standard).
The resulting sensitivity and specificity were 0.90 and 0.80 respectively.[11]
|
Baseline at Day 1 and post intervention at Day 5.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ali M ALSAQR, PHD, King Saud University
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB No. E-25-9589
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Occhio secco
-
University of California, San FranciscoThat Man May See, Inc.ReclutamentoPerdita evaporativa Dry Eye DiseaseStati Uniti
-
CEU San Pablo UniversityCompletatoDolore dopo il Dry Needling
-
Al-Quds UniversityCompletatoFisioterapia | Tecnica del Dry Needling | Mobilitazione MulliganTerritorio palestinese, occupato
-
CEU San Pablo UniversityCompletato
-
Yu-Hsin HsiehChang Gung University; Jonkoping University; Folke Bernadotte Stiftelsen; Stiftelsen... e altri collaboratoriCompletatoDisturbi della comunicazione | Dispositivi di auto-aiuto | Tecnologia Eye-Gaze | Gravi disabilità fisicheSvezia
-
Texas Woman's UniversityAttivo, non reclutanteDolore al collo | Dolore alla spalla | Aghi a secco | Dolore al collo Muscoloscheletrico | Tecnica del Dry NeedlingStati Uniti
-
Instituto de Investigación Sanitaria de la Fundación...University of AlcalaCompletatoColpo di frusta | Dolore all'articolazione temporomandibolare | Tecnica del Dry NeedlingSpagna
-
University of the Basque Country (UPV/EHU)FisioAraba Centre Physiotherapy S.C.; Toshiba Medical Systems, S.A.; Metron Medical... e altri collaboratoriCompletatoSindromi Dolorose Miofasciali | Elastografia | Dry Needling, Tecnica per il Trattamento dei Trigger Point MiofascialiSpagna
-
Tepecik Training and Research HospitalCompletatoEcografia | Sindrome del muscolo piriforme | Aghi a secco | Dry Needling ecoguidato | Esercizio di trattamentoTacchino
-
Universiteit AntwerpenRevalidatieziekenhuis RevArteTerminatoDolore neuropatico | Lesioni del midollo spinale | Spasticità | Tecnica del Dry NeedlingBelgio