NCT04678115

Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will evaluate two non-surgical devices designed to improve eye lid opening for patients with severe Blepharoptosis (incomplete opening of the eyelids).

Detailed description

Two non-surgical devices for patients with Blepharoptosis will be evaluated. The Magnetic Levator Prosthesis (MLP), is an external device that makes use of a newer class of permanent magnets (made of alloys of neodymium (Nd), iron (Fe) and boron (B)) to restore eyelid movement. The Kinesiotape Frontalis Sling (KTFS), involves the use of tape to help facilitate levator muscle contraction to open the eyelid. Video recordings of spontaneous and volitional blinks will be used to evaluate the effects of each device on eyelid reanimation. The clinical trial will employ a crossover design in which participants will try each device at home in counterbalanced order with a washout period between. In each period of the crossover, participants will receive training (during study visits at Massachusetts Eye and Ear) in how to apply the device and will then try the device at home for one week with daily follow up by video calls. At the end of the one-week period of home use there will be a study visit at Massachusetts Eye and Ear when the device will be returned and additional video recordings of eye blinks will be made. At the end of the crossover period, participants will be asked to complete a questionnaire comparing the two devices and to select their preferred device.

Conditions

• Blepharoptosis
• Ptosis, Eyelid
• Myasthenia Gravis
• Stroke
• Traumatic Brain Injury
• Chronic Progressive External Ophthalmoplegia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-12-21
• Last updated: 2025-04-22
• Results posted: 2025-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study