Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

NACompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
BlepharoptosisPtosis, EyelidMyasthenia GravisStrokeTraumatic Brain InjuryChronic Progressive External Ophthalmoplegia
Interventions
DEVICE

Magnetic Levator Prosthesis (MLP)

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.

DEVICE

Kinesiotape Frontalis Sling (KTFS)

Kineso Tape is FDA registered as a 510K exempt class 1 device, typically used by physical and occupational therapist to support muscular healing and movement. It is sometimes used on the face in cases of facial palsy or on the eye lid to support the lid in cases of severe blepharoptosis. In such cases it may be attached near the lid margin above the lashes extending up to the forehead skin overlying the frontalis muscle. Alternatively it may be a very short piece attached only along the lid skin. The tape is easily removed.

Trial Locations (1)

02114

Massachusetts Eye and Ear, Boston

All Listed Sponsors
collaborator

National Eye Institute (NEI)

NIH

lead

Massachusetts Eye and Ear Infirmary

OTHER