Clinical Trial to Improve the Magnetic Levator Prosthesis

NCT03818204 | Completed Results

• 1 other identifier: 18-166H
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device could restore eyelid movement. A newer class of permanent magnets made of alloys of neodymium (Nd), iron (Fe) and boron (B) might provide the technology needed to develop a feasible external magnetic device that could restore eyelid movement.

Conditions

Blepharoptosis; Ptosis, Eyelid; Myasthenia Gravis; Stroke; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Change in Interpalpebral Fissure During Eye Opening

  Change in interpalpebral fissure (resting open) at 5 different force settings of the rotatable adjustable force system.

  6 minutes, 1 minute for each rotation position.

Study Arms (6)

Experimental Group baseline

NO INTERVENTION

Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with no device.

Experimental Group MLP 0 degree orientation

EXPERIMENTAL

Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 0 degrees polarization angle.

Device: Magnetic Levator Prosthesis (MLP)

Experimental Group MLP 30 Degree Orientation

EXPERIMENTAL

Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 30 degrees polarization angle.

Device: Magnetic Levator Prosthesis (MLP)

Experimental Group MLP 60 Degree Orientation

EXPERIMENTAL

Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 60 degrees polarization angle.

Device: Magnetic Levator Prosthesis (MLP)

Experimental Group MLP 90 Degree Orientation

EXPERIMENTAL

Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 90 degrees polarization angle.

Device: Magnetic Levator Prosthesis (MLP)

Experimental Group MLP 180 Degree Orientation

EXPERIMENTAL

Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 180 degrees polarization angle.

Device: Magnetic Levator Prosthesis (MLP)

Interventions

Magnetic Levator Prosthesis (MLP) DEVICE

Neodymium magnet embedded in a glasses frame and a polymer embedded (PDMS) micro-magnet array fitted externally to the upper lid with IV 3000 securement film. The IV 3000 is FDA approved for extended wear on the skin. Tegaderm, which is essentially the same adhesive, is even FDA approved as an eye covering (we used Tegaderm in early studies but switched to IV 3000 for its superior ease of handling based on packaging technique).

Experimental Group MLP 0 degree orientation; Experimental Group MLP 180 Degree Orientation; Experimental Group MLP 30 Degree Orientation; Experimental Group MLP 60 Degree Orientation; Experimental Group MLP 90 Degree Orientation

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Schepens Eye Research Institute

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Blepharoptosis; Myasthenia Gravis; Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Kevin Houston
• Organization: VA Central Western Massachusetts

kevin.houston2@va.gov

781-588-7674

Study Officials

• Kevin Houston, OD, M. Sc.

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masked/blinded clinical staff will apply the lid magnets polarized either through thickness or through height (counterbalanced) to the study subjects. Also, 10 magnets of different sizes will be placed inside a plastic housing in order to prevent bias (participant and clinical staff will not know the actual size of the magnets) and counterbalance to control for order effect.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Model Details: This is a prospective cross-over study with some aims having double-blind methodology. Randomization and masking will be used in aims 1 and 2 experiments. Aim 1: The spectacle magnet will be rotated to 1 of 4 settings in an order which will be counterbalanced using a Latin Square approach. Patient and experimenters will be masked to the actual force setting. Aim 2: 17 participants were randomized to be fitted first with either through thickness or through height polarization of the lid magnets using an online randomizer by a study staff not involved in the data collection or analysis who will keep the code. Every other subject in the sequence will be balanced to receive the alternative order. Counterbalancing is being used because of the small sample size.

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 28, 2019
• Study Start: February 7, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Locations

US (1)