NCT03812016

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: E-DA Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Blepharoptosis
• Device Usability

Interventions

Type	Name	Description
DEVICE	Feedback-enabled magnetic device	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.

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-01-22
• Last updated: 2025-05-14

Locations

2 sites across 1 country: Taiwan