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Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

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ClinicalTrials.gov Identifier: NCT04678115
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : October 10, 2022
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Kevin Houston, Massachusetts Eye and Ear Infirmary

Brief 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).

Condition or disease Intervention/treatment Phase
Blepharoptosis Ptosis, Eyelid Myasthenia Gravis Stroke Traumatic Brain Injury Chronic Progressive External Ophthalmoplegia Device: Magnetic Levator Prosthesis (MLP) Device: Kinesiotape Frontalis Sling (KTFS) Not Applicable

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. If considered clinically appropriate, participants may be invited to continue using the preferred device for an additional two months with weekly follow ups to provide information about longer-term use of the intervention. Participants who are still using one of the devices at the end of the two months will be returned to clinical care and receive a study follow up (telephone call) after another 6 and 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : May 18, 2023
Estimated Study Completion Date : July 1, 2024


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.




Primary Outcome Measures :
  1. Difference between MLP and KTFS in the change in interpalpebral fissure during opening and spontaneous blinking [ Time Frame: Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) ]
    Measurements of the interpalpebral fissure will be taken from video recordings of eye lid opening and closing when using each of the devices


Secondary Outcome Measures :
  1. Difference between MLP and KTFS in the changes in interpalpebral fissure during volitional blinking [ Time Frame: Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) ]
    Measurements of the interpalpebral fissure will be taken from video recordings of volitional eye lid closing when using each of the devices

  2. Proportion of subjects selecting each device [ Time Frame: At the end of the one-week period of home use of the second device ]
    Proportion of subjects selecting either the MLP, the KTFS or neither



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678115


Contacts
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Contact: Kevin Houston, OD MSc 617-573-4177 Kevin_Houston@meei.harvard.edu
Contact: Sheryl Erwin, BS 617-573-6533 sheryl_erwin@meei.harvard.edu

Locations
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United States, Massachusetts
Massachusetts Eye and Ear Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kevin Houston, OD MSc    617-573-4177    kevin_houston@meei.harvard.edu   
Contact: Sheryl Erwin, BS    617-573-6533    sheryl_erwin@meei.harvard.edu   
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
National Eye Institute (NEI)
Investigators
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Principal Investigator: Kevin Houston, OD MSc Massachusetts Eye and Ear
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Responsible Party: Kevin Houston, Assistant Professor, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT04678115    
Other Study ID Numbers: 2019P003055
R01EY029437 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022

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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
Additional relevant MeSH terms:
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Myasthenia Gravis
Ophthalmoplegia, Chronic Progressive External
Brain Injuries
Brain Injuries, Traumatic
Ophthalmoplegia
Blepharoptosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Eyelid Diseases
Eye Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Paralysis
Neurologic Manifestations
Mitochondrial Myopathies