A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis
Comparison of Treatment Outcomes for Blepharoptosis of Various Etiologies Using a Feedback-enabled Magnetic Device
1 other identifier
interventional
40
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2019
CompletedFirst Posted
Study publicly available on registry
January 22, 2019
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 14, 2025
May 1, 2025
3.8 years
January 17, 2019
May 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Evaluate the efficacy by measuring changes in distance.
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.
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.
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
Secondary Outcomes (2)
Evaluate the efficacy by measuring changes in distance 1 month and 6 months after surgical intervention.
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.
1 month and 6 months after surgical intervention
Study Arms (1)
Determine device feasibility
EXPERIMENTALby evaluating efficacy and safety of the device. Test the device (duration: 120 mins/each time). Intervention: using the feedback-enabled magnetic device.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with ptosis; they are capable of understanding and complying with protocol requirements
- Aged 18 years old or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- E-DA Hospitallead
- National Yang Ming Chiao Tung Universitycollaborator
- The Industrial Technology Research Institutecollaborator
- Shin Kong Wu Ho-Su Memorial Hospitalcollaborator
- National Science and Technology Council, Taiwancollaborator
Study Sites (2)
E-Da Hospital
Kaohsiung City, 82445, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Related Publications (1)
Lien CF, Lin BS, Wu TM, Lin YC, Chang RC, Cheng CK, Yeh JH, Jeng SF. Efficacy and Safety of a Magnetic Device for Temporary Management of Blepharoptosis: Single-Arm Open-Label Trial. Otolaryngol Head Neck Surg. 2025 Nov;173(5):1111-1120. doi: 10.1002/ohn.1350. Epub 2025 Jul 16.
PMID: 40671431DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yuan-Kun Tu
E-Da Hospital, Kaohsiung, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy head of the Department of Otolaryngology-Head and Neck Surgery, E-Da Hospital
Study Record Dates
First Submitted
January 17, 2019
First Posted
January 22, 2019
Study Start
April 1, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 14, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share