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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY029437 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Proportion of Non-closure During Volitional Blinks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Houston, OD MSc | Massachusetts Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25674358 | Background | 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. | |
| 29367892 | Background | Houston 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. |
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Upon written request to Massachusetts Eye and Ear data may be provided
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One candidate was ruled as ineligible at a pre-screening visit due to lack of blepharoptosis.
Data for this study were collected at Massachusetts Eye and Ear, Boston, MA. Subjects were recruited by flyer and by referral from other ophthalmology clinics, or neurology clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. This was a cross-over study in which participants received each the Magnetic Levator Prosthesis (MLP) and the Kinesiotape Frontalis Sling (KTFS) devices in counterbalanced order with a washout period between the two interventions. Additionally, the participants also completed a training period for each device prior to the week of at home use, where participants completed baseline assessments with each respective Device and during the MLP training they also underwent assessment using a Sham MLP 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2024 |
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| 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. |
|
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 | Proportion of subjects selecting either the MLP, the KTFS or neither | 6 weeks |
| 36269183 | Background | Houston 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. |
| 37566397 | Background | Kurukuti 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. |
| 38038607 | Background | Tirandazi 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. |
| 34123530 | Background | Cheatham 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. |
| 8565190 | Background | Lemp 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. |
| 39932468 | Result | Houston 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. |
| FG001 | 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. This was a cross-over study in which participants received each the Magnetic Levator Prosthesis (MLP) and the Kinesiotape Frontalis Sling (KTFS) devices in counterbalanced order with a washout period between the two interventions. Additionally, the participants also completed a training period for each device prior to the week of at home use, where participants completed baseline assessments with each respective Device and during the MLP training they also underwent assessment using a Sham MLP 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. 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. |
| COMPLETED |
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| NOT COMPLETED |
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The subject that was lost to follow up did not contribute any data to the analysis. No data was collected at their first study visit and so we felt it was best not to report as part of the baseline demographics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Baseline characteristics were calculated for the entire group. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline Interpalpebral Fissure | Mean | Standard Deviation | millimeters |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | millimeters | 2 weeks |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | millimeters | 2 weeks |
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| Secondary | 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. | Posted | Number | Proportion of Non-closure Blinks | 2 weeks |
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| Secondary | Proportion of Subjects Selecting Each Device | Proportion of subjects selecting either the MLP, the KTFS or neither | All 15 participants were asked to chose which device they liked better, or no device. They were still masked to which was the novel/experimental treatment. | Posted | Count of Participants | Participants | 6 weeks |
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8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnetic Levator Prosthesis (MLP) | Data from when the participants were wearing the MLP. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Kinesiotape Frontalis Sling (KTFS) | Data from when participants were wearing the KTFS. | 0 | 15 | 0 | 15 | 3 | 15 |
| EG002 | Baseline (Sham) | Data from when participants were wearing a sham MLP device. Data acts as a baseline + placebo effect. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in skin erythema scale >3 points | Eye disorders | Systematic Assessment | Industry skin erythema rating scale |
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| Increase in conjunctival staining >2 points | Eye disorders | Systematic Assessment | NEI industry scale for ocular surface staining |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Houston | VA Central Western Massachusetts | 781-588-7674 | kevin.houston2@va.gov |
| Mar 18, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| D009157 | Myasthenia Gravis |
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| D017246 | Ophthalmoplegia, Chronic Progressive External |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D017240 | Mitochondrial Myopathies |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D028361 | Mitochondrial Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Power Calculation: Sample size was estimated based on the treatment condition (three-level factor) effect size on the spontaneous blink IPF measurements (0.55) after eight participants had completed the crossover using one-way analysis of variance power calculation. This led to a sample size of 12 participants with power of 0.80 and type II error of alpha 0.05. To account for possible attrition, 16 were enrolled, with 15 completing the crossover. |
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