Efficacy and Safety of a Magnetic Device for Temporary Management of Blepharoptosis: Single-Arm Open-Label Trial.
Ching-Feng Lien, Bor-Shyh Lin, Tzong-Ming Wu...
https://pubmed.ncbi.nlm.nih.gov/40671431Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID03812016
Comparison of Treatment Outcomes for Blepharoptosis of Various Causes Using a Feedback-Enabled Magnetic Device
Led by E-DA Hospital · Updated on 2025-05-14
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
E
E-DA Hospital
Lead Sponsor
N
National Yang Ming Chiao Tung University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new feedback-enabled magnetic device designed to temporarily manage blepharoptosis, a condition where the upper eyelid droops. The study aims to evaluate how well the device improves eyelid height, symmetry of blinks, and reduces symptoms like visual field obstruction, blurred vision, and discomfort on the eyelid and surrounding skin. The safety and effectiveness of this device will be compared with outcomes from patients who undergo surgery for the same condition. The device includes near-infrared sensors, a magnetic actuator, an iron sheet for attaching to the affected eyelid, and a biosignal module. During the study, participants will use the device for sessions lasting about 120 minutes each. Researchers will measure the distance the eyelid lifts and assess muscle activity related to eyelid movement. Both subjective sensations and any side effects will be monitored to evaluate the device’s performance. Participants will have their eyelid measurements taken before and after using the device, along with assessments of visual field changes and muscle activity. These evaluations occur shortly after device use and include checking for any skin irritation or discomfort. The study also includes follow-up examinations comparing device use with surgical treatment outcomes at one and six months. The total participation time for each device use session is about two hours, with longer-term follow-up for surgical cases.
CONDITIONS
Brief Title
A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with ptosis who can understand and follow the study procedures
- Aged 18 years or older
You will not qualify if you...
- Upper eyelid scar, contracture, or fibrosis from prior surgery
- Psychiatric or mental disorders preventing cooperation
- Children younger than 18 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 2 hours per device testing session
Participants use the feedback-enabled magnetic device for temporary management of blepharoptosis. The device testing lasts approximately 120 minutes each time, and efficacy and safety are assessed during and shortly after use.
1 visit (in-person) for device testing and immediate assessments
Follow-up
Duration - 6 months
Participants who undergo surgical intervention are evaluated for efficacy and complications at 1 month and 6 months after surgery.
2 visits (in-person) at 1 month and 6 months post-surgery
Trial Site Locations
Total: 2 locations
1
E-Da Hospital
Kaohsiung City, Taiwan, 82445
Actively Recruiting
2
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Actively Recruiting
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Research Team
C
Ching-Feng Lien, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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