N/A
N=19
Clinical Trial to Improve the Magnetic Levator Prosthesis
Blepharoptosis · Ptosis, Eyelid · Myasthenia Gravis · Stroke · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT03818204 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Interpalpebral Fissure During Eye Opening — 4.5; 6.9; 6.2; 6.3 millimeters — p=>=0.46
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic Levator Prosthesis (MLP) (Device)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Interpalpebral Fissure During Eye Opening |
4.5; 6.9; 6.2; 6.3; 6.4; 7.1 | >=0.46 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Experimental:
- 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.
- Age less than 5,
- 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.
Data sourced from ClinicalTrials.gov (NCT03818204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.