BlepharoptosisNCT04678115
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
A study testing Magnetic Levator Prosthesis (MLP) and Kinesiotape Frontalis Sling (KTFS) in people with Blepharoptosis and Ptosis, Eyelid, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis
- What is being tested?
- Magnetic Levator Prosthesis (MLP) and Kinesiotape Frontalis Sling (KTFS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 31 Dec 2024
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
About this study
Official title: 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).
Read the 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.
- Conditions
- Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis, Stroke, Traumatic Brain Injury, Chronic Progressive External Ophthalmoplegia
- Being tested
- Magnetic Levator Prosthesis (MLP), Kinesiotape Frontalis Sling (KTFS)
- Medical subject headings
- Blepharoptosis, Myasthenia Gravis, Stroke, Brain Injuries, Traumatic, Ophthalmoplegia, Chronic Progressive External
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.
Kinesiotape Frontalis Sling (KTFS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| MLP first, KTFS second | Experimental | Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period. Receives: Device: Magnetic Levator Prosthesis (MLP); Device: Kinesiotape Frontalis Sling (KTFS) |
| KTFS first, MLP second | Experimental | Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period. Receives: Device: Magnetic Levator Prosthesis (MLP); Device: Kinesiotape Frontalis Sling (KTFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpalpebral Fissure (IPF) During Spontaneous Blink
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.
Measured: 2 weeks
Secondary outcomes (3)
Interpalpebral Fissure During Resting Open
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.
Measured: 2 weeks
Proportion of Non-closure During Volitional Blinks
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.
Measured: 2 weeks
Proportion of Subjects Selecting Each Device
Proportion of subjects selecting either the MLP, the KTFS or neither
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Jun 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Kevin Houston, Massachusetts Eye and Ear Infirmary
- Investigators
- Kevin Houston, OD MSc, Principal investigator, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678115
- Sponsor's protocol ID
- 2019P003055
- Other IDs
- R01EY029437
- Status last verified
- Apr 2025
- First submitted
- 14 Dec 2020
- Last updated
- 22 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Upon written request to Massachusetts Eye and Ear data may be provided
Publications
Houston KE, Tomasi M, Yoon M, Paschalis EI. A Prototype External Magnetic Eyelid Device for Blepharoptosis. Transl Vis Sci Technol. 2014 Dec 17;3(6):9. doi: 10.1167/tvst.3.6.9. eCollection 2014 Oct.
PubMed 25674358Houston KE, Tomasi M, Amaral C, Finch N, Yoon MK, Lee H, Paschalis EI. The Magnetic Levator Prosthesis for Temporary Management of Severe Blepharoptosis: Initial Safety and Efficacy. Transl Vis Sci Technol. 2018 Jan 19;7(1):7. doi: 10.1167/tvst.7.1.7. eCollection 2018 Jan.
PubMed 29367892Houston KE, Paschalis EI. Feasibility of Magnetic Levator Prosthesis Frame Customization Using Craniofacial Scans and 3-D Printing. Transl Vis Sci Technol. 2022 Oct 3;11(10):34. doi: 10.1167/tvst.11.10.34.
PubMed 36269183Kurukuti NM, Nadeau M, Paschalis EI, Houston KE. An Adjustable Magnetic Levator Prosthesis for Customizable Eyelid Re-Animation in Severe Blepharoptosis: Design and Proof-of-Concept. Transl Vis Sci Technol. 2023 Aug 1;12(8):11. doi: 10.1167/tvst.12.8.11.
PubMed 37566397Tirandazi P, Nadeau M, Woods RL, Paschalis EI, Houston KE. An Adjustable Magnetic Levator Prosthesis for Customizable Eyelid Reanimation in Severe Blepharoptosis II: Randomized Evaluation of Angular Translation. Transl Vis Sci Technol. 2023 Dec 1;12(12):1. doi: 10.1167/tvst.12.12.1.
PubMed 38038607Cheatham SW, Baker RT, Abdenour TE. Kinesiology Tape: A Descriptive Survey of Healthcare Professionals in the United States. Int J Sports Phys Ther. 2021 Jun 1;16(3):778-796. doi: 10.26603/001c.22136.
PubMed 34123530Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. No abstract available.
PubMed 8565190Houston KE, Pundlik S, Shivshanker P, Bowers AR, LaRosa S, Robinson M, Chodosh J, Brandes L, Lee P, Paschalis EI. A Single-Center Sham and Active-Controlled Double-Blind Randomized Crossover Trial of the Magnetic Levator Prosthesis for Severe Blepharoptosis. Transl Vis Sci Technol. 2025 Feb 3;14(2):15. doi: 10.1167/tvst.14.2.15.
PubMed 39932468
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
- ClinicalTrials.gov ID
- NCT04678115
- Acronym / sponsor ID
- 2019P003055
- Conditions
- Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis, Stroke, Traumatic Brain Injury, Chronic Progressive External Ophthalmoplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 22 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MLP first, KTFS second | Experimental | Device: Magnetic Levator Prosthesis (MLP), Device: Kinesiotape Frontalis Sling (KTFS)Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period. |
| KTFS first, MLP second | Experimental | Device: Magnetic Levator Prosthesis (MLP), Device: Kinesiotape Frontalis Sling (KTFS)Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- 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;
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. | Device | KTFS first, MLP second, MLP first, KTFS second |
| 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. | Device | KTFS first, MLP second, MLP first, KTFS second |
Primary outcome
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.
3 secondary outcomes
Interpalpebral Fissure During Resting Open
Time frame: 2 weeks
Proportion of Non-closure During Volitional Blinks
Time frame: 2 weeks
Proportion of Subjects Selecting Each Device
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25674358Houston KE, Tomasi M, Yoon M, Paschalis EI. A Prototype External Magnetic Eyelid Device for Blepharoptosis. Transl Vis Sci Technol. 2014 Dec 17;3(6):9. doi: 10.1167/tvst.3.6.9. eCollection 2014 Oct.
- Background: PubMed 29367892Houston KE, Tomasi M, Amaral C, Finch N, Yoon MK, Lee H, Paschalis EI. The Magnetic Levator Prosthesis for Temporary Management of Severe Blepharoptosis: Initial Safety and Efficacy. Transl Vis Sci Technol. 2018 Jan 19;7(1):7. doi: 10.1167/tvst.7.1.7. eCollection 2018 Jan.
- Background: PubMed 36269183Houston KE, Paschalis EI. Feasibility of Magnetic Levator Prosthesis Frame Customization Using Craniofacial Scans and 3-D Printing. Transl Vis Sci Technol. 2022 Oct 3;11(10):34. doi: 10.1167/tvst.11.10.34.
- Background: PubMed 37566397Kurukuti NM, Nadeau M, Paschalis EI, Houston KE. An Adjustable Magnetic Levator Prosthesis for Customizable Eyelid Re-Animation in Severe Blepharoptosis: Design and Proof-of-Concept. Transl Vis Sci Technol. 2023 Aug 1;12(8):11. doi: 10.1167/tvst.12.8.11.
- Background: PubMed 38038607Tirandazi P, Nadeau M, Woods RL, Paschalis EI, Houston KE. An Adjustable Magnetic Levator Prosthesis for Customizable Eyelid Reanimation in Severe Blepharoptosis II: Randomized Evaluation of Angular Translation. Transl Vis Sci Technol. 2023 Dec 1;12(12):1. doi: 10.1167/tvst.12.12.1.
- Background: PubMed 34123530Cheatham SW, Baker RT, Abdenour TE. Kinesiology Tape: A Descriptive Survey of Healthcare Professionals in the United States. Int J Sports Phys Ther. 2021 Jun 1;16(3):778-796. doi: 10.26603/001c.22136.
- Background: PubMed 8565190Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. No abstract available.
- Results publication: PubMed 39932468Houston KE, Pundlik S, Shivshanker P, Bowers AR, LaRosa S, Robinson M, Chodosh J, Brandes L, Lee P, Paschalis EI. A Single-Center Sham and Active-Controlled Double-Blind Randomized Crossover Trial of the Magnetic Levator Prosthesis for Severe Blepharoptosis. Transl Vis Sci Technol. 2025 Feb 3;14(2):15. doi: 10.1167/tvst.14.2.15.
- Individual participant dataSharing planned: No. Upon written request to Massachusetts Eye and Ear data may be provided
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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 MSc principal investigator
Massachusetts Eye and Ear
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) and Kinesiotape Frontalis Sling (KTFS) 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 2 inclusion and 12 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 22 Apr 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 22 Apr 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?
Interpalpebral Fissure (IPF) During Spontaneous Blink (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678115, which also lists 8 linked publications.
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 22 Apr 2025.