A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorE-DA Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with ptosis; they are capable of understanding and complying with protocol requirements
Aged 18 years old or older
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Feedback-enabled magnetic device
DeviceThe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Determine device feasibilityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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 testing3
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 testingSecondary outcomes
1
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.2
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 interventionSponsors and contacts
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E-DA Hospital
Lead sponsor
National Yang Ming Chiao Tung University
Collaborator
The Industrial Technology Research Institute
Collaborator
Shin Kong Wu Ho-Su Memorial Hospital
Collaborator
National Science and Technology Council, Taiwan
Collaborator
Source ClinicalTrials.gov