Un dispositif magnétique en temps réel pour la gestion temporaire de la blépharoptose
Un dispositif magnétique en temps réel pour la gestion de la blépharoptose
To develop a feedback-enabled magnetic device for management of blepharoptosis and evaluate its efficacy and safety, including the gain of palpebral fissure height, visual field obstruction, blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid, by performing a human trial on patients with blepharoptosis.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The feedback-enabled magnetic device primarily comprises 2 matched pairs of one near-infrared light-emitting diode and one photodiode sensor, a magnetic actuator, an iron sheet (for affixing to the paralytic upper eyelid), and a biosignal acquisition module along with a power supply unit providing a wired connection with optical sensors and a magnetic actuator. Before the study, the differences between the affected and unaffected palpebral fissure heights were directly measured using a ruler. During the test after using the device, the distance of the paralytic eyelid lift was documented and the corrected distance (gain) of the paralytic upper eyelid was calculated. The efficacy and safety of the device were assessed. The efficacy was evaluated according to the symmetrical blinks and gain of paralytic eyelid lifts. Subjective sensation and complications were assessed by visual field obstruction, blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid. After the completion of the study procedure, the eyelid skin integrity, subjective sensation and discomfort were examined. Outcomes in the management of blepharoptosis of diverse etiologies using a feedback-enabled magnetic device will be demonstrated. Differences in outcomes between patients managed using the device and those who underwent surgery will be presented.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ching-Feng Lien, MD, PhD
- Numéro de téléphone: 886-975106033
- E-mail: lien980206@yahoo.com.tw
Lieux d'étude
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Kaohsiung City, Taïwan, 82445
- Recrutement
- E-Da Hospital
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Contact:
- Ching-Feng Lien, MD, PhD
- Numéro de téléphone: 886-975106033
- E-mail: lien980206@yahoo.com.tw
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Taipei, Taïwan
- Recrutement
- Shin Kong Wu Ho-Su Memorial Hospital
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Contact:
- Jiann-Horng Yeh, MD
- Numéro de téléphone: 2071 886-228332211
- E-mail: m001074@ms.skh.org.tw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with ptosis; they are capable of understanding and complying with protocol requirements
- Aged 18 years old or older
Exclusion Criteria:
- Upper eyelid scar, contracture, or fibrosis due to previous surgical intervention(s)
- Patients with psychiatric (or mental) disorders; they are unable to cooperate or follow the study procedure
- Children younger than 18 years of age
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Determine device feasibility
by evaluating efficacy and safety of the device. Test the device (duration: 120 mins/each time). Intervention: using the feedback-enabled magnetic device. |
The device comprises 1 or 2 matched pairs of one near-infrared light-emitting diode and one sensor, a magnetic actuator, an iron sheet, and a biosignal acquisition module. The efficacy and safety were assessed using the feedback-enabled magnetic device. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluate the efficacy by measuring changes in distance.
Délai: 10-minutes after completion of the device testing.
|
The investigators assess changes (in millimeter) of palpebral fissure height and visual field obstruction before any intervention and during the device intervention by a ruler and a software. |
10-minutes after completion of the device testing.
|
|
Evaluate visual field changes and discomfort of blurred vision, cornea, upper eyelid, and skin before and after the device use based on a 3-point Likert scale.
Délai: 10-minutes after completion of the device testing
|
The investigators score questionnaires by assessing visual field changes and discomfort of blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid after device use. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 3 indicating no discomfort, score 2 mild to moderate discomfort, and score 1 severe discomfort. |
10-minutes after completion of the device testing
|
|
Evaluate frontalis muscle use by measuring changes in muscle activities in both amplitude and fluctuation.
Délai: 10-minutes after completion of the testing
|
The investigators assess electrical activities of the frontalis muscle and calculate total electromyographic areas (sum of all areas under the curve) before and after the device intervention. |
10-minutes after completion of the testing
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluate the efficacy by measuring changes in distance 1 month and 6 months after surgical intervention.
Délai: 1 month and 6 months after completion of surgical intervention.
|
The investigators assess changes (in millimeter) of palpebral fissure height and visual field obstruction after surgical intervention (performed after completion of the device intervention) by a ruler and a software. |
1 month and 6 months after completion of surgical intervention.
|
|
Evaluate visual field changes and complications 1 month and 6 months after surgical intervention based on a 3-point Likert scale.
Délai: 1 month and 6 months after surgical intervention
|
The investigators score questionnaires by assessing visual field changes and complications (including cosmetic results, headache relief, undercorrection, infection, foreign body tissue reaction, lagophthalmos, and keratitis). For visual field changes based on the 3-point Likert scale, the scale ranges from 1 to 3 with score 3 indicating good outcomes, score 2 fair outcomes, and score 1 poor outcomes; for complications, with score 3 indicating no discomfort (satisfied), score 2 mild to moderate discomfort (somewhat satisfied), and score 1 severe discomfort (dissatisfied). |
1 month and 6 months after surgical intervention
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Yuan-Kun Tu, E-Da Hospital, Kaohsiung, Taiwan
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EDAHP107026
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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