BlepharoptosisNCT03818204
Clinical Trial to Improve the Magnetic Levator Prosthesis
A study testing Magnetic Levator Prosthesis (MLP) in people with Blepharoptosis and Ptosis, Eyelid, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device could restore eyelid movement. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis
- What is being tested?
- Magnetic Levator Prosthesis (MLP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Experimental:
- Presence of ptosis for at least one eye which obscures 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
- Age 5 or older
Who cannot join
- Experimental:
- Absence of blepharoptosis or presence of a corneal ulcer.
- Those with a corneal ulcer are at risk for permanent loss of vision and should be managed with proven methods.
- Age less than 5,
- Severe Cognitive impairment defined as MMSE score <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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Schepens Eye Research Institute
Boston, Massachusetts, 02114
About this study
Official title: Clinical Trial to Improve the Magnetic Levator Prosthesis (MLP) Including the Development and Testing of a Novel Adjustable Force System
Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device could restore eyelid movement. A newer class of permanent magnets made of alloys of neodymium (Nd), iron (Fe) and boron (B) might provide the technology needed to develop a feasible external magnetic device that could restore eyelid movement.
Read the detailed description
Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device, if able to generate an appropriately balanced force, could restore eyelid movement by performing the paralyzed function; for example, a ptotic (droopy) eyelid could be opened, and the functioning eyelid closure muscle could overcome the device's force (Conway, 1973; Barmettler et. al, 2014; Houston et. al, 2014). Despite this seemingly straight-forward application, permanent magnets for eyelid movement disorders have not thus far become an available treatment. It is possible that earlier magnetic materials lacked the strength (at sizes which were acceptable to patients) to effectively restore the blink, or methods of implantation or external mounting were not effective. A newer class of permanent magnets made of alloys of neodymium (Nd), iron (Fe) and boron (B) might provide the technology needed to develop a feasible external magnetic device. They generate the strongest static magnetic fields yet possible, (1.3T compared to 0.4T of conventional ferrite magnets) (Cyrot, 2005) with exceptional uniaxial magnetocrystalline anisotropy, which makes them resistive to demagnetization (Chikazumui, 1997). The increased magnetic force at a fraction of the size has led to attempts for other medical applications including implantation for gastroesophageal reflux disease (Ganz, 2013), in dental prosthetics (Uribe, 2006), ocular reconstructive surgery (de Negreiros, 2012), and glaucoma (Paschalis et. al, 2013). Problems with extended external non-surgical adhesion to the skin of the eyelid may be solved with hydrocolloid-based medical adhesives e.g. Tegaderm™ (Chen, 1997), already used for IV catheter securement, wound dressing, and as a protective eye covering (FDA, 1997). This material is extremely thin, transparent, and oxygen permeable with an established safety profile for days to weeks of wear. The hydrophyllic properties (FDA, 1997) may be beneficial to the eyelids, which are often moist. In our prior work we established proof-of-concept data demonstrating safety and efficacy for temporary management ptosis up to 2 hour per day for 2 weeks. Due to the sensitive force distance relationship characteristics of magnetic fields and variable nature of ptosis (often worsens throughout the day) the MLP required frequent readjustment and consistent correction was difficult to achieve. Other challenges included lid redness with longer wear times (in the participants who wore the MLP longer than instructed), incomplete spontaneous blinking, and difficultly with self-application of the magnetic lid array to the eye lid. This study aims to address these challenges. In order to improve the MLP we will determine the range of force in the target severe ptosis population to open the lid and where blinking is inhibited, determine the best polarity combination between the lid magnets and the spectacle magnet, determine if rotating the spectacle magnet is a good method to allow simple force adjustment via a dial on the side of the frame, determine if custom made frames improve stability of the frame, and create an applicator tool to help participants apply the lid magnet themselves.
- Being tested
- Magnetic Levator Prosthesis (MLP)
- Medical subject headings
- Blepharoptosis, Myasthenia Gravis, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Levator Prosthesis (MLP)Device
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. Tegaderm, which is essentially the same adhesive, is even FDA approved as an eye covering (we used Tegaderm in early studies but switched to IV 3000 for its superior ease of handling based on packaging technique).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group baseline | No intervention | Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with no device. |
| Experimental Group MLP 0 degree orientation | Experimental | Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 0 degrees polarization angle. Receives: Device: Magnetic Levator Prosthesis (MLP) |
| Experimental Group MLP 30 Degree Orientation | Experimental | Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 30 degrees polarization angle. Receives: Device: Magnetic Levator Prosthesis (MLP) |
| Experimental Group MLP 60 Degree Orientation | Experimental | Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 60 degrees polarization angle. Receives: Device: Magnetic Levator Prosthesis (MLP) |
| Experimental Group MLP 90 Degree Orientation | Experimental | Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 90 degrees polarization angle. Receives: Device: Magnetic Levator Prosthesis (MLP) |
| Experimental Group MLP 180 Degree Orientation | Experimental | Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 180 degrees polarization angle. Receives: Device: Magnetic Levator Prosthesis (MLP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interpalpebral Fissure During Eye Opening
Change in interpalpebral fissure (resting open) at 5 different force settings of the rotatable adjustable force system.
Measured: 6 minutes, 1 minute for each rotation position.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start7 Feb 2019
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a prospective cross-over study with some aims having double-blind methodology. Randomization and masking will be used in aims 1 and 2 experiments. Aim 1: The spectacle magnet will be rotated to 1 of 4 settings in an order which will be counterbalanced using a Latin Square approach. Patient and experimenters will be masked to the actual force setting. Aim 2: 17 participants were randomized to be fitted first with either through thickness or through height polarization of the lid magnets using an online randomizer by a study staff not involved in the data collection or analysis who will keep the code. Every other subject in the sequence will be balanced to receive the alternative order. Counterbalancing is being used because of the small sample size.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Houston, Massachusetts Eye and Ear Infirmary
- Investigators
- Kevin Houston, OD, M. Sc., Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818204
- Sponsor's protocol ID
- 18-166H
- Status last verified
- May 2025
- First submitted
- 23 Jan 2019
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Improve the Magnetic Levator Prosthesis (MLP) Including the Development and Testing of a Novel Adjustable Force System
- ClinicalTrials.gov ID
- NCT03818204
- Acronym / sponsor ID
- 18-166H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device could restore eyelid movement. A newer class of permanent magnets made of alloys of neodymium (Nd), iron (Fe) and boron (B) might provide the technology needed to develop a feasible external magnetic device that could restore eyelid movement.
Detailed description
Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device, if able to generate an appropriately balanced force, could restore eyelid movement by performing the paralyzed function; for example, a ptotic (droopy) eyelid could be opened, and the functioning eyelid closure muscle could overcome the device's force (Conway, 1973; Barmettler et. al, 2014; Houston et. al, 2014). Despite this seemingly straight-forward application, permanent magnets for eyelid movement disorders have not thus far become an available treatment. It is possible that earlier magnetic materials lacked the strength (at sizes which were acceptable to patients) to effectively restore the blink, or methods of implantation or external mounting were not effective. A newer class of permanent magnets made of alloys of neodymium (Nd), iron (Fe) and boron (B) might provide the technology needed to develop a feasible external magnetic device. They generate the strongest static magnetic fields yet possible, (1.3T compared to 0.4T of conventional ferrite magnets) (Cyrot, 2005) with exceptional uniaxial magnetocrystalline anisotropy, which makes them resistive to demagnetization (Chikazumui, 1997). The increased magnetic force at a fraction of the size has led to attempts for other medical applications including implantation for gastroesophageal reflux disease (Ganz, 2013), in dental prosthetics (Uribe, 2006), ocular reconstructive surgery (de Negreiros, 2012), and glaucoma (Paschalis et. al, 2013). Problems with extended external non-surgical adhesion to the skin of the eyelid may be solved with hydrocolloid-based medical adhesives e.g. Tegaderm™ (Chen, 1997), already used for IV catheter securement, wound dressing, and as a protective eye covering (FDA, 1997). This material is extremely thin, transparent, and oxygen permeable with an established safety profile for days to weeks of wear. The hydrophyllic properties (FDA, 1997) may be beneficial to the eyelids, which are often moist. In our prior work we established proof-of-concept data demonstrating safety and efficacy for temporary management ptosis up to 2 hour per day for 2 weeks. Due to the sensitive force distance relationship characteristics of magnetic fields and variable nature of ptosis (often worsens throughout the day) the MLP required frequent readjustment and consistent correction was difficult to achieve. Other challenges included lid redness with longer wear times (in the participants who wore the MLP longer than instructed), incomplete spontaneous blinking, and difficultly with self-application of the magnetic lid array to the eye lid. This study aims to address these challenges. In order to improve the MLP we will determine the range of force in the target severe ptosis population to open the lid and where blinking is inhibited, determine the best polarity combination between the lid magnets and the spectacle magnet, determine if rotating the spectacle magnet is a good method to allow simple force adjustment via a dial on the side of the frame, determine if custom made frames improve stability of the frame, and create an applicator tool to help participants apply the lid magnet themselves.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- This is a prospective cross-over study with some aims having double-blind methodology. Randomization and masking will be used in aims 1 and 2 experiments. Aim 1: The spectacle magnet will be rotated to 1 of 4 settings in an order which will be counterbalanced using a Latin Square approach. Patient and experimenters will be masked to the actual force setting. Aim 2: 17 participants were randomized to be fitted first with either through thickness or through height polarization of the lid magnets using an online randomizer by a study staff not involved in the data collection or analysis who will keep the code. Every other subject in the sequence will be balanced to receive the alternative order. Counterbalancing is being used because of the small sample size.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group baseline | No intervention | –Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with no device. |
| Experimental Group MLP 0 degree orientation | Experimental | Device: Magnetic Levator Prosthesis (MLP)Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 0 degrees polarization angle. |
| Experimental Group MLP 30 Degree Orientation | Experimental | Device: Magnetic Levator Prosthesis (MLP)Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 30 degrees polarization angle. |
| Experimental Group MLP 60 Degree Orientation | Experimental | Device: Magnetic Levator Prosthesis (MLP)Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 60 degrees polarization angle. |
| Experimental Group MLP 90 Degree Orientation | Experimental | Device: Magnetic Levator Prosthesis (MLP)Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 90 degrees polarization angle. |
| Experimental Group MLP 180 Degree Orientation | Experimental | Device: Magnetic Levator Prosthesis (MLP)Subjects with ptosis had their interpalpebral fissure measured continuously for 1 minute with the MLP set at 180 degrees polarization angle. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Experimental:
- Presence of ptosis for at least one eye which obscures 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
- Age 5 or older
Key exclusion criteria (5 listed)
- Experimental:
- Absence of blepharoptosis or presence of a corneal ulcer.
- Those with a corneal ulcer are at risk for permanent loss of vision and should be managed with proven methods.
- Age less than 5,
- Severe Cognitive impairment defined as MMSE score <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. Tegaderm, which is essentially the same adhesive, is even FDA approved as an eye covering (we used Tegaderm in early studies but switched to IV 3000 for its superior ease of handling based on packaging technique). | Device | Experimental Group MLP 0 degree orientation, Experimental Group MLP 180 Degree Orientation, Experimental Group MLP 30 Degree Orientation, Experimental Group MLP 60 Degree Orientation, Experimental Group MLP 90 Degree Orientation |
Primary outcome
Change in Interpalpebral Fissure During Eye Opening
Time frame: 6 minutes, 1 minute for each rotation position.
Change in interpalpebral fissure (resting open) at 5 different force settings of the rotatable adjustable force system.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Houston, OD, M. Sc. principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Levator Prosthesis (MLP) in people with Blepharoptosis and Ptosis, Eyelid, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interpalpebral Fissure During Eye Opening (time frame: 6 minutes, 1 minute for each rotation position.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.