Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-03 @ 5:02 AM
Study NCT ID:
NCT03848260
Status:
SUSPENDED
Last Update Posted:
2025-08-14
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-Time Magnetic Device Prototype for Temporary Management of Paralytic Lagophthalmos
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092164', 'term': 'Lagophthalmos'}, {'id': 'D020330', 'term': 'Bell Palsy'}], 'ancestors': [{'id': 'D005132', 'term': 'Eye Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'whyStopped': 'Although six patients completed the test using device prototype before Dec 2019, but due to the large size and shape, we failed to well miniaturize and manufacture a resilient system that stands the test of time for the future trial.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-09', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in palpebral gap from the baseline.', 'timeFrame': '10 minutes after completion of the testing', 'description': 'The investigators assess changes in distance between the upper and lower eyelid margins at the axis of the pupil (palpebral gap, millimeter) before and during the intervention by a ruler and/or a software.'}, {'measure': 'Changes in visual acuity (blurred vision) from the baseline.', 'timeFrame': '10 minutes after completion of the testing', 'description': 'Assess visual acuity by Snellen test before and after the intervention.'}, {'measure': 'Discomfort of the eyeball and condition of the upper eyelid and facial skin based on a dichotomous Likert scale.', 'timeFrame': '10 minutes after completion of the testing', 'description': 'The investigator assess discomfort of the eyeball, and examine erythema or swelling over upper eyelid and facial skin after the intervention. (The score 0 indicating no discomfort, score 1 indicating positive discomfort)'}, {'measure': 'Changes in palpebral gap from the baseline.', 'timeFrame': '10 minutes after completion of the second testing within 12 months', 'description': 'The investigators assess changes in distance between the upper and lower eyelid margins at the axis of the pupil (palpebral gap, millimeter) before and during the intervention by a ruler and/or a software.'}, {'measure': 'Changes in visual acuity (blurred vision) from the baseline.', 'timeFrame': '10 minutes after completion of the second testing within 12 months', 'description': 'Assess visual acuity by Snellen test before and after the intervention.'}, {'measure': 'Discomfort of the eyeball and degree of the upper eyelid and facial skin based on a 3-point Likert scale.', 'timeFrame': '10 minutes after completion of the second testing within 12 months', 'description': 'The investigator assess discomfort of the eyeball, and examine erythema or swelling over upper eyelid and facial skin after the intervention. The scale ranges from 1 to 3, with score 1 indicating no discomfort at all, score 2 moderate discomfort, and score 3 extremely discomfort.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lagophthalmos', 'Incomplete eye closure', 'Magnetic device', 'Blink restoration', 'Facial nerve palsy'], 'conditions': ['Paralytic Lagophthalmos']}, 'descriptionModule': {'briefSummary': 'To develop a real-time wearable device based on the principle of magnetic force for temporary management of lagophthalmos, and evaluate its efficacy and safety, including synchronous blinks and eye closure, blurred vision, foreign body sensation over cornea or eyeball, burning or hot sensation over facial skin, and erythema or pruritus over eyelid, by performing a human trial on patients with lagophthalmos.', 'detailedDescription': 'The wearable system includes a near-infrared (NIR) light-emitting diode (SMT910, Epitex Inc, Kyoto, Japan) and receiver (PD15-22C TR8, Everlight Electronics Corporation, New Taipei City, Taiwan), a permanent electromagnetic actuator (JNP-12/12, Joint Magnetic Technology Corporation, Shenzhen, China), an iron sheet affixed to the paralytic upper eyelid, and a bio-signal acquisition module together with a power supply unit providing a wired connection to the NIR sensor and permanent electromagnetic actuator. The palpebral gap was measured before and after the wearing of the device. The efficacy of the device prototype was assessed in terms of synchronous blinks and eye closure. Subjective sensation and complications were assessed by blurred vision, foreign body sensation over cornea or eyeball, burning or hot sensation over facial skin, and erythema or pruritus over eyelid. After the completion of the study procedure, eyelid skin condition was examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with unilateral lagophthalmos; they are capable of understanding and complying with protocol requirements\n* Aged 18 years old or older\n\nExclusion Criteria:\n\n* Upper eyelid scar, contracture, fibrosis, and atrophy due to previous surgical intervention(s)\n* Patients with psychiatric (or mental) disorders; they are unable to cooperate or follow the study procedure\n* Children younger than 18 years of age'}, 'identificationModule': {'nctId': 'NCT03848260', 'briefTitle': 'A Real-Time Magnetic Device Prototype for Temporary Management of Paralytic Lagophthalmos', 'organization': {'class': 'OTHER', 'fullName': 'E-DA Hospital'}, 'officialTitle': 'A Real-Time Magnetic Device Prototype for Management of Paralytic Lagophthalmos', 'orgStudyIdInfo': {'id': 'EMRP33106N'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Determine device feasibility', 'description': 'by evaluating efficacy and safety of the device prototype. Test the device one time (duration: 60-120 mins/each time) and second time within 12 months.\n\nIntervention: using the magnetic device prototype', 'interventionNames': ['Device: Magnetic device prototype']}], 'interventions': [{'name': 'Magnetic device prototype', 'type': 'DEVICE', 'description': 'The device prototype comprises a near-infrared light-emitting diode (SMT910, Epitex Inc, Kyoto, Japan) and receiver (PD15-22C TR8, Everlight Electronics Corporation, New Taipei City, Taiwan), a permanent electromagnetic actuator (JNP-12/12, Joint Magnetic Technology Corporation, Shenzhen, China), an iron sheet affixed to the paralytic upper eyelid, and a bio-signal acquisition module. The efficacy and safety of the device prototype was assessed using the device prototype.', 'armGroupLabels': ['Determine device feasibility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82445', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'E-DA Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Yuan-Kun Tu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'E-Da Hospital, Kaohsiung, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'E-DA Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, {'name': 'The Industrial Technology Research Institute', 'class': 'OTHER'}, {'name': 'I-Shou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy head of the Department of Otolaryngology-Head and Neck Surgery, E-Da Hospital', 'investigatorFullName': 'Lien, Ching-Feng', 'investigatorAffiliation': 'E-DA Hospital'}}}}