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Permanent Magnet
Clinical Trial to Improve the Magnetic Levator Prosthesis
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
No Placebo-Only Group
Summary
This trial tests a new magnetic device to help patients with severe droopy eyelids. The device uses strong magnets to lift the eyelid, making it easier for patients to open their eyes. This approach targets those who haven't found relief with other treatments. A prototype external magnetic eyelid device has been previously tested and shown to be effective in providing eye opening with high comfort scores.
Eligible Conditions
- Drooping Eyelid
- Myasthenia Gravis
- Blepharoptosis
- Stroke
- 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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in interpalpebral fissure during eye opening
Secondary study objectives
Change in interpalpebral fissure during the blink
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Levator Prosthesis (MLP)
2019
N/A
~20
Find a Location
Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
109 Previous Clinical Trials
12,664 Total Patients Enrolled
Kevin Houston, OD, M. Sc.Principal InvestigatorMass Eye and Ear