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Custom Print Megnetic Levator Prosthesis Pilot Comparison

NCT04807855 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-03-19

No results posted yet for this study

Summary

Study the device feasibility of non-surgical treatment for blepharoptosis (inability to open the eyelid) consisting of a biocompatible magnetic element adhered to the upper eyelid and a second magnet above the eye on a custom 3D-printed eyeglasses frame with a dial to provide adjustable magnetic force to open the eye while still allowing eye closure.

Conditions

  • Blepharoptosis

Interventions

DEVICE

The cMLP device

There is only one medical device we are testing, so only one intervention.

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    collaborator OTHER

  • Skelmet Inc

    lead INDUSTRY

Principal Investigators

  • Yu Cao, Mr · Skelmet Inc

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • United States

Study Locations

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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 NCT04807855 on ClinicalTrials.gov