A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis

E-DA Hospital

Status: Enrolling

Conditions: Blepharoptosis; Device Usability

Treatments: Device: Feedback-enabled magnetic device

Study type: Interventional

Funder types: Other

Identifiers

NCT03812016

EDAHP107026

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with 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)
• 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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Determine device feasibility

Experimental group

Description:

by evaluating efficacy and safety of the device. Test the device (duration: 120 mins/each time). Intervention: using the feedback-enabled magnetic device.

Treatment:

Device: Feedback-enabled magnetic device