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A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis

NCT03812016 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

  • Blepharoptosis
  • Device Usability

Interventions

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.

Sponsors & Collaborators

  • National Yang Ming Chiao Tung University

    collaborator OTHER

  • The Industrial Technology Research Institute

    collaborator OTHER

  • Shin Kong Wu Ho-Su Memorial Hospital

    collaborator OTHER

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • E-DA Hospital

    lead OTHER

Principal Investigators

  • Yuan-Kun Tu · E-Da Hospital, Kaohsiung, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812016 on ClinicalTrials.gov