Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blepharoptosis | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Ptosis, Eyelid | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
| Traumatic Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Levator Prosthesis (MLP) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- NO_INTERVENTION
- label
- Experimental Group baseline
- description
- Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with no device.
- type
- EXPERIMENTAL
- label
- Experimental Group MLP 0 degree orientation
- description
- Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 0 degrees polarization angle.
- interventionNames
- Device: Magnetic Levator Prosthesis (MLP)
- type
- EXPERIMENTAL
- label
- Experimental Group MLP 30 Degree Orientation
- description
- Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 30 degrees polarization angle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available