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

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
Sagging Breasts
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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

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

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