An interventional study of Feedback-enabled magnetic device in Blepharoptosis and Device Usability, sponsored by E-DA Hospital. Recruiting at 2 sites in Taiwan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by E-DA Hospital · Not applicable, Interventional, and Treatment
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.
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.
75 studies on the registry are indexed under Blepharoptosis; 14 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 56 interventional studies indexed under Blepharoptosis.
Browse Blepharoptosis studies →E-DA Hospital is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
by evaluating efficacy and safety of the device. Test the device (duration: 120 mins/each time). Intervention: using the feedback-enabled magnetic device.
Device: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 10-minutes after completion of the testing
Evaluate the efficacy by measuring changes in distance 1 month and 6 months after 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.
Time frame: 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.
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).
Time frame: 1 month and 6 months after surgical intervention
Plan to share: No
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