Clinical Trial to Improve the Magnetic Levator Prosthesis

Completed · Not applicable

Conditions studied: Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis, Stroke, Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT03818204

Run by

Massachusetts Eye and Ear Infirmary

People needed

19

Starts

2019-02-07

Expected to finish

2023-12-01

Last updated by the study team

2025-06-13

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Schepens Eye Research Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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