Custom Print Megnetic Levator Prosthesis Pilot Comparison

Completed · Early Phase 1

Conditions studied: Blepharoptosis

In brief

Study the device feasibility of non-surgical treatment for blepharoptosis (inability to open the eyelid) consisting of a biocompatible magnetic element adhered to the upper eyelid and a second magnet above the eye on a custom 3D-printed eyeglasses frame with a dial to provide adjustable magnetic force to open the eye while still allowing eye closure.

Key facts

Study ID

NCT04807855

Run by

Skelmet Inc

People needed

16

Starts

2019-04-01

Expected to finish

2020-03-31

Last updated by the study team

2021-03-19

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of Blepharoptosis for at least one eye, 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. Sex - All. Gender Based - All.

You may not qualify if…

• Absence of Blepharoptosis. Age less than 5, Severe Cognitive impairment defined as Mini-mental score less than 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. Healthy Volunteers.

Where it is running

• Mass. Eye and Ear — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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