Device for managing eyelid drooping
Comparison of Treatment Outcomes for Blepharoptosis of Various Etiologies Using a Feedback-enabled Magnetic Device
This study tests a new device that helps lift drooping eyelids for people with blepharoptosis to see if it works better than surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | E-DA Hospital Academic / other |
| Locations | 2 sites (Kaohsiung City and 1 other locations) |
| Trial ID | NCT03812016 on ClinicalTrials.gov |
What this trial studies
This study evaluates a feedback-enabled magnetic device designed to temporarily manage blepharoptosis, a condition characterized by drooping eyelids. The device uses near-infrared light sensors and a magnetic actuator to lift the paralytic upper eyelid and restore blink symmetry. Participants will undergo assessments to measure the effectiveness of the device in improving eyelid height and reducing symptoms such as visual obstruction and discomfort. The study aims to compare outcomes between patients using the device and those who have undergone surgical interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with blepharoptosis who can comply with the study protocol.
Not a fit: Patients with previous eyelid surgeries or those with psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a non-surgical option for patients suffering from blepharoptosis, improving their quality of life.
How similar studies have performed: While there have been various approaches to managing blepharoptosis, the use of a feedback-enabled magnetic device is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kaohsiung City and 1 other locations
- E-Da Hospital — Kaohsiung City, Taiwan (Recruiting)
- Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Ching-Feng Lien, MD, PhD
- Email: lien980206@yahoo.com.tw
- Phone: 886-975106033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.