Clinical trial NCT03812016: A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis
Official title: Comparison of Treatment Outcomes for Blepharoptosis of Various Etiologies Using a Feedback-enabled Magnetic Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blepharoptosis
Device Usability
Keywords: Blepharoptosis
Blink restoration
Magnetic device
Oculomotor nerve palsy
Ptosis
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
Collaborators: name: National Yang Ming Chiao Tung University
name: The Industrial Technology Research Institute
name: Shin Kong Wu Ho-Su Memorial Hospital
name: National Science and Technology Council, Taiwan
First posted: 2019-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the efficacy by measuring changes in distance.
timeFrame: 10-minutes after completion of the device testing.
measure: 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.
timeFrame: 10-minutes after completion of the device testing
measure: Evaluate frontalis muscle use by measuring changes in muscle activities in both amplitude and fluctuation.
timeFrame: 10-minutes after completion of the testing
Secondary outcomes:
measure: Evaluate the efficacy by measuring changes in distance 1 month and 6 months after surgical intervention.
timeFrame: 1 month and 6 months after completion of surgical intervention.
measure: Evaluate visual field changes and complications 1 month and 6 months after surgical intervention based on a 3-point Likert scale.
timeFrame: 1 month and 6 months after surgical intervention
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: E-Da Hospital, Kaohsiung, Taiwan
name: Yuan-Kun Tu
role: STUDY_CHAIR
References: