N/A
N=11
Magnetic Correction of Eye Lid Paralysis
Blepharoptosis · Lagophthalmos · Facial Paralysis
Bottom Line
View on ClinicalTrials.gov: NCT02988856 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Rating Scale of Skin Integrity — 0.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic lid system (Device)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Kevin Houston
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rating Scale of Skin Integrity |
0.3 | — |
| SECONDARY Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale |
1 | — |
| SECONDARY Change in Visual Acuity |
0.03 | — |
Summary
Objective 1: Determine the safety and feasibility of externally mounted magnets for extended management of chronic eyelid movement disorders by measuring visual acuity and corneal and skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on the relative efficacy of external magnetic devices by comparing them to externally mounted lid weights and ptosis crutches using rating scales and video analysis of blink biomechanics.
Eligibility Criteria
Inclusion Criteria
- Presence of an eyelid movement disorder 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.
Exclusion Criteria
- Absence of an eyelid movement disorder 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 Mini-mental 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.
Data sourced from ClinicalTrials.gov (NCT02988856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.