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
E-DA Hospital
40 participants
Apr 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Patients with ptosis; they are capable of understanding and complying with protocol requirements
- Aged 18 years old or older
Exclusion Criteria3
- 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
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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.
Locations(2)
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NCT03812016