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Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

NCT04678115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-04-22

Study results available
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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).

Conditions

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.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Kevin Houston, OD MSc · Massachusetts Eye and Ear

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678115 on ClinicalTrials.gov