Status:
COMPLETED
Clinical Trial to Improve the Magnetic Levator Prosthesis
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Blepharoptosis
Ptosis, Eyelid
Eligibility:
All Genders
4+ years
Phase:
NA
Brief Summary
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 n...
Detailed Description
Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device, if able to generate an appropriat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03818204
Start Date
February 7 2019
End Date
December 1 2023
Last Update
June 13 2025
Active Locations (1)
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1
Schepens Eye Research Institute
Boston, Massachusetts, United States, 02114