Clinical Trial to Improve the Magnetic Levator Prosthesis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT03818204
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Feb 7, 2019
Status verified
May 2025
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: Experimental Group baseline
    Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with no device.
  • Experimental: Experimental Group MLP 0 degree orientation
    Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 0 degrees polarization angle.
  • Experimental: Experimental Group MLP 30 Degree Orientation
    Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 30 degrees polarization angle.
  • Experimental: Experimental Group MLP 60 Degree Orientation
    Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 60 degrees polarization angle.
  • Experimental: Experimental Group MLP 90 Degree Orientation
    Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 90 degrees polarization angle.
  • Experimental: Experimental Group MLP 180 Degree Orientation
    Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 180 degrees polarization angle.

Primary Outcome Measure

Change in Interpalpebral Fissure During Eye Opening [ Time Frame: 6 minutes, 1 minute for each rotation position. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Schepens Eye Research InstituteBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Schepens Eye Research Institute· Boston, MA

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