Clinical Trial to Improve the Magnetic Levator Prosthesis
Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis
About this trial
This is an interventional treatment trial for Blepharoptosis
Eligibility Criteria
Inclusion Criteria:
- 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
- Control/Normal Vision Group:
- Absence of ptosis which obscures the visual axis
- Age 18 or older
Exclusion Criteria:
- 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.
- Control/Normal Vision Group:
- Presence of Blepharoptosis
- Age less than 18
Sites / Locations
- Schepens Eye Research Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Experimental Group
Control/Normal Vision Group
The purpose of the experimental group is to test the intervention. Participants will have their acuity measured (refraction as needed), slit lamp with Nafl & NEI scale, visual functioning questionnaire (VFQ), cognitive assessment (MOCA).The eye lid will be prepped and video recorded.The masked clinical staff will then apply the polarized magnets and perform a number of measurements to ascertain effectiveness of intervention. -Intervention - Magnetic Levator Prosthesis (MLP)
The purpose of the normal vision group is to test the experimental setup prior to enrolling ptosis patients. If the measurements of the normal vision group are found to be non-different to the experimental group, the data will be pooled. -Intervention - Magnetic Levator Prosthesis (MLP)