NCT03818204Completed
Clinical Trial to Improve the Magnetic Levator Prosthesis
Clinical Trial to Improve the Magnetic Levator Prosthesis (MLP) Including the Development and Testing of a Novel Adjustable Force System
Source: ClinicalTrials.gov · Last updated 13 Jun 2025
Brief summary (registry, in English)
Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device could restore eyelid movement. A newer class of permanent magnets made of alloys of neodymium (Nd), iron (Fe) and boron (B) might provide the technology needed to develop a feasible external magnetic device that could restore eyelid movement.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 23 Jan 2019
- Start date
- 7 Feb 2019
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Diseases
- Myasthenia gravis, Stroke
- NCT number
- NCT03818204
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 7 Feb 2019 to the primary completion date, 1 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Absence of blepharoptosis or presence of a corneal ulcer.
- Those with a corneal ulcer are at risk for permanent loss of vision and should be managed with proven methods.
- Severe Cognitive impairment defined as MMSE score \<18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy. These individuals must be excluded since participation requires competent self-care, reliable responses and cooperation during fitting of the devices.
Age
- Age less than 5,
Other
- Experimental:
Who the study is looking for
- Experimental:
- Presence of ptosis for at least one eye which obscures the visual axis in the resting position (without frontalis drive, lifting with forehead muscles)
- Moderate cognitive function or better defined as greater than or equal to 18 out of 30 on a pre-screening of the Mini-Mental State Exam
- Age 5 or older
Age in the registry: 4 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Schepens Eye Research Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.