Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

April 8, 2025 updated by: Kevin Houston, Massachusetts Eye and Ear Infirmary

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Presence of ptosis for at least one eye which occludes the visual axis in the resting position (without frontalis drive, lifting with forehead muscles)
  • 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 (MMSE)

Exclusion Criteria:

  • Absence of ptosis which occludes the visual axis
  • Presence of a corneal ulcer of any size
  • Age less than 5 years
  • Severe Cognitive impairment defined as MMSE score less than 18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy.
  • Presence of corneal hypoaesthesia;
  • Orbicularis weakness on the side of the ptosis
  • Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
  • Previous ptosis surgery less than 3 months prior to Visit 1.
  • Lid position affected by lid or conjunctival scarring.
  • History of herpes keratitis.
  • Periocular neurotoxin (eg, Botox, Xeomin, Dysport, Myobloc) injections on the side of the ptosis within 3 months prior to Visit 1 and during the study.
  • History of hyperthyroidism or thyroid eye disease (ie, exophthalmos, upper eyelid retraction, diplopia secondary to extraocular muscle involvement). Hypothyroidism that is controlled on medication is allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MLP first, KTFS second
Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.
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.
Experimental: KTFS first, MLP second
Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interpalpebral Fissure (IPF) During Spontaneous Blink
Time Frame: 2 weeks
The primary outcome was objective measurement of the IPF midpoint height during maximum closing in five spontaneous blinks, captured with a Nikon mirrorless SLR video recording system (Z7II; Nikon USA, Melville, NY, USA), with a visible light source mounted just above the lens, measured manually with ImageJ (National Institutes of Health, Bethesda, MD, USA). Spontaneous blinks are normally incomplete, a behavior that is dependent upon age, gender, task, and environmental demands. Maximum closing was defined as the three points at the base of the blink. Participants were instructed to look at the camera lens and try to relax and behave normally. Recording was stopped after 1 minute or after five spontaneous blinks, whichever came first. Recording always occurred in the same windowless clinical research room with consistent lighting, temperature, humidity, and air flow. The IPF midpoint height during maximum closing in five spontaneous blinks is averaged and reported below.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interpalpebral Fissure During Resting Open
Time Frame: 2 weeks
Resting open IPF was the median between blink-event IPF, measured automatically by a deep learning model for eyelid landmark detection. the IPF midpoint height during resting open was averaged and reported below.
2 weeks
Proportion of Non-closure During Volitional Blinks
Time Frame: 2 weeks
At the end of recording, participants were instructed to close their eyes completely and open completely three times, representing volitional blink trials. These were evaluated manually with ImageJ. Blinks were classified by a human rater as having complete closure, or not, and then the proportion of non-closure blinks across all subjects was calculated for each condition and reported below.
2 weeks
Proportion of Subjects Selecting Each Device
Time Frame: 6 weeks
Proportion of subjects selecting either the MLP, the KTFS or neither
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Eye and Ear Infirmary

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: Kevin Houston, OD MSc, Massachusetts Eye and Ear

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P003055
  • R01EY029437 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Upon written request to Massachusetts Eye and Ear data may be provided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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