A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis

Not Applicable

Recruiting

• Conditions: Blepharoptosis; Device Usability
• Interventions: Device: Magnetic device

• Registration Number: NCT03812016
• Lead Sponsor: E-DA Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-22
• Study Start: 2023-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Determine device feasibility	Magnetic device	by evaluating efficacy and safety of the device. Test the device one time ( duration: 60-120 mins/each time) and second time within 12 months. Intervention: using the magnetic device

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy by measuring changes in distance.	10-minutes after completion of the device testing.	The investigators assess changes (in millimeter) of palpebral fissure height and visual field obstruction before any intervention and during the device intervention by a ruler and a software.
Evaluate visual field changes and discomfort of blurred vision, cornea, upper eyelid, and skin before and after the device use based on a 3-point Likert scale.	10-minutes after completion of the device testing	The investigators score questionnaires by assessing visual field changes and discomfort of blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid after device use. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 3 indicating no discomfort, score 2 mild to moderate discomfort, and score 1 severe discomfort.
Evaluate frontalis muscle use by measuring changes in muscle activities in both amplitude and fluctuation.	10-minutes after completion of the testing	The investigators assess electrical activities of the frontalis muscle and calculate total electromyographic areas (sum of all areas under the curve) before and after the device intervention.

Secondary Outcome Measures

Name	Time	Method
Evaluate the efficacy by measuring changes in distance 1 month and 6 months after surgical intervention.	1 month and 6 months after completion of surgical intervention.	The investigators assess changes (in millimeter) of palpebral fissure height and visual field obstruction after surgical intervention (performed after completion of the device intervention) by a ruler and a software.
Evaluate visual field changes and complications 1 month and 6 months after surgical intervention based on a 3-point Likert scale.	1 month and 6 months after surgical intervention	The investigators score questionnaires by assessing visual field changes and complications (including cosmetic results, headache relief, undercorrection, infection, foreign body tissue reaction, lagophthalmos, and keratitis). For visual field changes based on the 3-point Likert scale, the scale ranges from 1 to 3 with score 3 indicating good outcomes, score 2 fair outcomes, and score 1 poor outcomes; for complications, with score 3 indicating no discomfort (satisfied), score 2 mild to moderate discomfort (somewhat satisfied), and score 1 severe discomfort (dissatisfied).

Trial Locations

Locations (2)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan

E-Da Hospital; 🇨🇳 Kaohsiung, Taiwan