Blepharoptosis Clinical Trial
Official title:
A Real-time Magnetic Device for Management of Blepharoptosis
To develop a real-time magnetic device prototype for temporary management of blepharoptosis and evaluate its efficacy and safety, including the gain of palpebral fissure height, visual axis 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 unilateral blepharoptosis.
The magnetic device prototype primarily comprises 2 matched pairs of one near-infrared light-emitting diode and one photodiode sensor, a permanent electromagnetic 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 permanent electromagnetic actuator. Before the study, the differences between the affected and unaffected palpebral fissure heights were directly measured using a ruler. During the test after the wearing of the prototype, 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 prototype were assessed. The efficacy was evaluated according to the synchronous blinks and gain of paralytic eyelid lifts. Subjective sensation and complications were assessed by visual axis 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. ;
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