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Objective 1: Determine the safety and feasibility of externally mounted magnets for extended management of chronic eyelid movement disorders by measuring visual acuity and corneal and skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on the relative efficacy of external magnetic devices by comparing them to externally mounted lid weights and ptosis crutches using rating scales and video analysis of blink biomechanics.
Two major types of eye lid movement disorders include lagophthalmos (incomplete closure of the eyelids) and blepharoptosis (incomplete opening of the eyelids). Both of these conditions occur because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. Generally paralysis of the eyelid or facial muscles is responsible for the abnormality (the eyelids can close but not open, or open but not close). 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. In prior work the investigators established proof-of-concept data demonstrating safety and efficacy for temporary management of ptosis up to 2 hour per day for 2 weeks. Preliminary data suggest similar safety for lagophthalmos. This study will expand on this preliminary work to examine longer wear times, home use, and feasibility for a wider range of eye lid disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic lid system | Experimental | All participants will trial a commercially available device and an experimental magnetic device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic lid system | Device | Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing. |
| Measure | Description | Time Frame |
|---|---|---|
| Rating Scale of Skin Integrity | Ratings at the beginning and end of treatment will be analyzed by calculating the mean and standard deviation of the skin erythema rating across all available time points. The outcome measure is the FDA scale, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry. Range is 0 to 7 with higher numbers being worse skin erythema. | Baseline and up to 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale | Using the National Eye Institute Rating Scale (0 to 3 points with higher being more staining), cases where staining increased more than 2 points or if there was any ulceration, an adverse event was tabulated and summed for each participant over 1 up to 32 weeks of use, depending on how long the participant was followed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin E Houston, OD | Massachusetts Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology of Clinical Research Office, Mass Eye and Ear | Boston | Massachusetts | 021141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Singh NK, Paschalis EI, Tomasi M, Rizzo JF, Houston KE. The boston blink-netic project: preliminary outpatient feasibility results (abstract). Optom Vis Sci 2016;93: E-abstract 16118. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnetic Lid System | Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnetic Lid System | All participants will trial a commercially available device and an experimental magnetic device. Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rating Scale of Skin Integrity | Ratings at the beginning and end of treatment will be analyzed by calculating the mean and standard deviation of the skin erythema rating across all available time points. The outcome measure is the FDA scale, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry. Range is 0 to 7 with higher numbers being worse skin erythema. | Erythema rating in participants who had worn the MLP for 1 to 32 weeks. All the ratings each subject had across all their visits were averaged, and then a group average and std dev calculated. | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 32 weeks |
|
1 week
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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 Lid System | All participants will trial a commercially available device and an experimental magnetic device. Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Houston | Massachusetts Eye and Ear | 617-573-4177 | kevin_houston@meei.harvard.edu |
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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 | Nov 20, 2018 | Aug 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| D000092164 | Lagophthalmos |
| D005158 | Facial Paralysis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D005132 | Eye Manifestations |
| D009059 | Mouth Diseases |
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|
| Baseline and up to 32 weeks |
| Change in Visual Acuity | Visual acuity at 20ft before treatment and after 1 week or more. Difference between weekly acuity measures to baseline was calculated and averaged for each subject, and then a group mean and standard deviation calculated. | Baseline and up to 32 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale | Using the National Eye Institute Rating Scale (0 to 3 points with higher being more staining), cases where staining increased more than 2 points or if there was any ulceration, an adverse event was tabulated and summed for each participant over 1 up to 32 weeks of use, depending on how long the participant was followed. | Participants with ptosis wearing the MLP for 1 or more weeks | Posted | Count of Participants | Participants | No | Baseline and up to 32 weeks |
|
|
|
| Secondary | Change in Visual Acuity | Visual acuity at 20ft before treatment and after 1 week or more. Difference between weekly acuity measures to baseline was calculated and averaged for each subject, and then a group mean and standard deviation calculated. | Participants who wore the MLP for 1 week or more | Posted | Mean | Standard Deviation | LogMAR | Baseline and up to 32 weeks |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 2 |
| 11 |
| Corneal staining | Eye disorders | Systematic Assessment | Increase in corneal staining over safety cutoff (>grade 2 increase) |
|
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| D009057 |
| Stomatognathic Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |