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Permanent Magnet
Magnetic Levator Prosthesis (MLP) for Drooping Eyelid
N/A
Waitlist Available
Led By Kevin Houston, OD, M. Sc.
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
Awards & highlights
Study Summary
This trial is testing whether a new class of permanent magnets can help people with a disruption in the normal agonist-antagonist neuro-muscular complex balance (which causes incomplete opening of the eyelids).
Eligible Conditions
- Drooping Eyelid
- Stroke
- Myasthenia Gravis
- Traumatic Brain Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in interpalpebral fissure during eye opening
Secondary outcome measures
Change in interpalpebral fissure during the blink
Trial Design
2Treatment groups
Experimental Treatment
Group I: Experimental GroupExperimental Treatment1 Intervention
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)
Group II: Control/Normal Vision GroupExperimental Treatment1 Intervention
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)
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Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,919 Total Patients Enrolled
Kevin Houston, OD, M. Sc.Principal InvestigatorMass Eye and Ear
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity for participants in this experiment?
"The records at clinicaltrials.gov show that this medical trial, initially posted on February 7th 2019 and edited most recently on April 4th 2022, has finished recruiting participants. However, there are presently 1366 other studies which have open registrations."
Answered by AI
Who else is applying?
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
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