Custom Print Megnetic Levator Prosthesis Pilot Comparison

NCT04807855 | Completed Early Phase 1 DMC

• 1 other identifier: Skelmet
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Blepharoptosis

Outcome Measures

Primary Outcomes (3)

• Resting interpalpebral fissure size

  Interpalpebral fissure is defined as the greatest distance between the upper and lower eye lid margins at the insertion point of the lashes. Resting is defined as point where the eyelid is maximally elevated.

  after 20 minutes of wear

• Patient decision to participate in a 20-min trial with the prototype MLP

  This is a binary response measure (1 = yes I would like to participate or 0 = no I would not like to participate.

  after 2 minutes of wear

• Comfort rating scale

  This measure is a 10 point likert-type rating scale used to quantify the comfort of the MLP (1 poor comfort to 10 high comfort).

  after 20 minutes of wear

Secondary Outcomes (3)

• Difference in the resting interpalpebral fissure size from highest to lowest magnetic force settings

  after 2 minutes of wear

• Interpalpebral fissure size at maximum blink

  after 2 minutes, 20 minutes, and 1-week of wear

• Frequency and severity of adverse events

  after 20 minutes and 1-week of wear

Study Arms (1)

the experimental arm

EXPERIMENTAL

All subjects, the ptosis group and the normal group receive the same intervention.

Device: The cMLP device

Interventions

The cMLP device DEVICE

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

the experimental arm

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of Blepharoptosis for at least one eye, moderate cognitive function or better defined as greater than or equal to 18 out of 30 on a pre-screening of the Mini-Mental State Exam, age 5 or older. Sex - All. Gender Based - All.

You may not qualify if:

• Absence of Blepharoptosis. Age less than 5, Severe Cognitive impairment defined as Mini-mental score less than 18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy. These individuals must be excluded since participation requires competent self-care, reliable responses and cooperation during fitting of the devices. Healthy Volunteers.

Sponsors & Collaborators

• Skelmet Inc: lead
• Massachusetts Eye and Ear Infirmary: collaborator

Study Sites (1)

Mass. Eye and Ear

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Yu Cao, Mr

  Skelmet Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: April 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)