A Real-time Magnetic Device Prototype for Temporary Management of Blepharoptosis
A Real-time Magnetic Device Prototype for Temporary 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.
Inclusion Criteria:

 -  Patients with unilateral ptosis; they are capable of understanding and complying with
 protocol requirements

 -  Aged 18 years old or older

 Exclusion Criteria:

 -  Upper eyelid scar, contracture, or fibrosis due to previous surgical intervention(s)
 or traffic accident

 -  Patients with psychiatric (or mental) disorders; they are unable to cooperate or
 follow the study procedure

 -  Children younger than 18 years of age