NCT Number: NCT03812016
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
E-Da Hospital, Kaohsiung City, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 10-minutes after completion of the device testing.
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
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 testing
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: 1 month and 6 months after completion of 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 surgical intervention
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).
Contact information is provided by the study sponsor or research team.
E-DA Hospital
Other
Comparison of Treatment Outcomes for Blepharoptosis of Various Etiologies Using a Feedback-enabled Magnetic Device
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