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出境医 / 临床实验 / A Real-time Magnetic Device Prototype for Temporary Management of Blepharoptosis

A Real-time Magnetic Device Prototype for Temporary Management of Blepharoptosis

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Blepharoptosis Device: Magnetic device prototype Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Real-time Magnetic Device Prototype for Management of Blepharoptosis
Actual Study Start Date : October 14, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : October 11, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Determine device feasibility

by evaluating efficacy and safety of the device prototype. Test the device one time ( duration: 30-120 mins/each time) and 3 times within 3 months.

Intervention: using the magnetic device prototype

 Device: Magnetic device prototype
The device prototype 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 of the device prototype were assessed using the device prototype.
Outcome Measures
Primary Outcome Measures :
  1. Evaluation of the efficacy by measuring changes in distance. [ Time Frame: 10-minutes after completion of the testing ]
    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.

  2. Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale. [ Time Frame: 10-minutes after completion of the testing ]
    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.

  3. Evaluation of the efficacy by measuring changes in distance. [ Time Frame: 3-months ]
    The investigators assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention (3 times) by a ruler and a software.

  4. Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale. [ Time Frame: 3-months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Ching-Feng Lien, MD 886-7-6150011 ext 5678 lien980206@yahoo.com.tw

Locations
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Taiwan
E-Da Hospital Recruiting
Kaohsiung, Taiwan, 82445
Contact: Ching-Feng Lien, MD    886-7-6150011 ext 5678    lien980206@yahoo.com.tw   
Sponsors and Collaborators
E-DA Hospital
Investigators
Layout table for investigator information
Study Chair: Yuan-Kun Tu E-Da Hospital, Kaohsiung, Taiwan
Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE October 14, 2018
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2019)
  • Evaluation of the efficacy by measuring changes in distance. [ Time Frame: 10-minutes after completion of the testing ]
    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.
  • Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale. [ Time Frame: 10-minutes after completion of the testing ]
    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.
  • Evaluation of the efficacy by measuring changes in distance. [ Time Frame: 3-months ]
    The investigators assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention (3 times) by a ruler and a software.
  • Evaluate discomfort of blurred vision, cornea, upper eyelid, and skin based on a 3-point Likert scale. [ Time Frame: 3-months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • Evaluation of the efficacy by measuring changes in distance. [ Time Frame: 10-minutes after completion of the testing ]
    We assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention by a ruler and a software.
  • Evaluation of the safety based on 3-point scale questionnaire. [ Time Frame: 10-minutes after completion of the testing ]
    We assess discomfort and severity 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. The severity is classified as none, mild, or moderate to severe level.
  • Evaluation of the efficacy by measuring changes in distance. [ Time Frame: 3-months ]
    We assess changes (in millimeter) of palpebral fissure height and visual axis obstruction before and during the intervention (3 times) by a ruler and a software.
  • Evaluation of the safety based on 3-point scale questionnaire. [ Time Frame: 3-months ]
    We assess discomfort and severity 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 (3 times). The severity is classified as none, mild, or moderate to severe level.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Real-time Magnetic Device Prototype for Temporary Management of Blepharoptosis
Official Title  ICMJE A Real-time Magnetic Device Prototype for Management of Blepharoptosis
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Blepharoptosis
Intervention  ICMJE Device: Magnetic device prototype
The device prototype 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 of the device prototype were assessed using the device prototype.
Study Arms  ICMJE Experimental: Determine device feasibility

by evaluating efficacy and safety of the device prototype. Test the device one time ( duration: 30-120 mins/each time) and 3 times within 3 months.

Intervention: using the magnetic device prototype

Intervention: Device: Magnetic device prototype
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 18, 2019) 		16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 11, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03812016
Other Study ID Numbers  ICMJE EDAHP107026
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tu, Yuan-Kun, E-DA Hospital
Study Sponsor  ICMJE E-DA Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yuan-Kun Tu E-Da Hospital, Kaohsiung, Taiwan
PRS Account E-DA Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP