Status:
COMPLETED
Custom Print Megnetic Levator Prosthesis Pilot Comparison
Lead Sponsor:
Skelmet Inc
Collaborating Sponsors:
Massachusetts Eye and Ear Infirmary
Conditions:
Blepharoptosis
Eligibility:
All Genders
5+ years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Detailed Description
Extensive description of the study protocol is provided in the Research Strategy (R), but key components are summarized and justified here. This is a prospective, interventional, single-arm, single-gr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04807855
Start Date
April 1 2019
End Date
March 31 2020
Last Update
March 19 2021
Active Locations (1)
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1
Mass. Eye and Ear
Boston, Massachusetts, United States, 02114