A Real-time Magnetic Device for Temporary Management of Blepharoptosis

Blepharoptosis Clinical Trial

Official title:

A Real-time Magnetic Device for Management of Blepharoptosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03812016
• Other study ID #: EDAHP107026
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: E-DA Hospital
• Contact: Ching-Feng Lien, MD
• Phone: 886-7-6150011
• Email: lien980206[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Blepharoptosis

Intervention

Device:
• Magnetic device
The device comprises 1 or 2 matched pairs of one near-infrared light-emitting diode (SMT910, Epitex Inc, Kyoto, Japan) and one sensor (PD15-22C TR8, Everlight Electronics Corporation, New Taipei City, Taiwan), a permanent electromagnetic actuator (JNP-12/12, Joint Magnetic Technology Corporation, Shenzhen, China), an iron sheet, and a biosignal acquisition module. The efficacy and safety were assessed using the magnetic device.

Locations

Country	Name	City	State
Taiwan	E-Da Hospital	Kaohsiung

Sponsors (3)

Lead Sponsor	Collaborator
E-DA Hospital	National Yang Ming Chiao Tung University, The Industrial Technology Research Institute

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the efficacy by measuring changes in distance.	The investigators assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention by a ruler and a software.	10-minutes after completion of the testing
Primary	Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale.	The investigators assess 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 the wearing of the device. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 1 indicating no discomfort at all, score 2 moderate discomfort, and score 3 extremely discomfort.	10-minutes after completion of the testing
Primary	Evaluation of the efficacy by measuring changes in distance.	The investigators assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention (second time) by a ruler and a software.	10-minutes after completion of the second testing (within 12 months)
Primary	Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale.	The investigators assess 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 the wearing of the device. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 1 indicating no discomfort at all, score 2 moderate discomfort, and score 3 extremely discomfort.	10-minutes after completion of the second testing (within 12 months)