Trial results for a study investigating a magnetic levator prosthesis for blepharoptosis, including cases related to stroke, were posted on ClinicalTrials.gov on 2025-06-13. The study reported mean interpalpebral fissure measurements ranging from 4.5 millimeters at baseline to 6.2-7.1 millimeters with the device.
Background
Blepharoptosis, characterized by incomplete opening of the eyelids, results from a disruption in the normal agonist-antagonist neuro-muscular complex balance. This condition can stem from various causes, including neurological events like stroke, as well as myasthenia gravis and traumatic brain injury. An external device capable of restoring eyelid movement could offer a non-surgical solution. Recent advancements in permanent magnets, specifically those made from neodymium, iron, and boron alloys, present a technological pathway for developing feasible external magnetic devices to address eyelid movement deficits.
Trial design
This completed study, designated as Phase NA, enrolled 19 participants. The trial investigated conditions including Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis, Stroke, and Traumatic Brain Injury. The intervention involved a magnetic levator prosthesis (MLP) designed to restore eyelid movement. The study aimed to improve this prosthesis.
Key results
The trial measured the change in interpalpebral fissure during eye opening across different orientations of the magnetic levator prosthesis:
- At baseline, the mean interpalpebral fissure was 4.5 millimeters.
- With the experimental group's MLP at 0-degree orientation, the mean fissure was 6.9 millimeters.
- With the experimental group's MLP at 30-degree orientation, the mean fissure was 6.2 millimeters.
- With the experimental group's MLP at 60-degree orientation, the mean fissure was 6.3 millimeters.
- With the experimental group's MLP at 90-degree orientation, the mean fissure was 6.4 millimeters.
- With the experimental group's MLP at 180-degree orientation, the mean fissure was 7.1 millimeters.
A linear mixed-effects model (multiple regression) was used to assess the effect of angular position on the interpalpebral fissure. The analysis yielded a p-value of 0.46, suggesting no statistically significant effect of angular position.
What this means
The results indicate that the magnetic levator prosthesis can increase the interpalpebral fissure during eye opening in individuals with blepharoptosis, including those whose condition is related to stroke. The observed mean increases from a baseline of 4.5 millimeters to a range of 6.2-7.1 millimeters across various device orientations suggest a functional improvement in eyelid opening. The linear regression analysis, with a p-value of 0.46, implies that the specific angular position of the prosthesis may not significantly influence the degree of eyelid opening, suggesting flexibility in device application.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03818204, titled "Clinical Trial to Improve the Magnetic Levator Prosthesis", were posted on 2025-06-13 on clinicaltrials.gov.