- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03818204
Clinical Trial to Improve the Magnetic Levator Prosthesis
Clinical Trial to Improve the Magnetic Levator Prosthesis (MLP) Including the Development and Testing of a Novel Adjustable Force System
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Schepens Eye Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Control/Normal Vision Group:
- Absence of ptosis which obscures the visual axis
- Age 18 or older
Exclusion Criteria:
- 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.
- Control/Normal Vision Group:
- Presence of Blepharoptosis
- Age less than 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
The purpose of the experimental group is to test the intervention. Participants will have their acuity measured (refraction as needed), slit lamp with Nafl & NEI scale, visual functioning questionnaire (VFQ), cognitive assessment (MOCA).The eye lid will be prepped and video recorded.The masked clinical staff will then apply the polarized magnets and perform a number of measurements to ascertain effectiveness of intervention. -Intervention - 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).
|
Other: Control/Normal Vision Group
The purpose of the normal vision group is to test the experimental setup prior to enrolling ptosis patients. If the measurements of the normal vision group are found to be non-different to the experimental group, the data will be pooled. -Intervention - 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in interpalpebral fissure during eye opening
Time Frame: This outcome will be analysed by reviewing video recording. Video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
|
A > 1mm change in interpalpebral fissure (resting open) at min and max force of the rotatable system; a >1mm change in interpalpebral fissure when the lid array is polarized through thickness as compared to through height.
|
This outcome will be analysed by reviewing video recording. Video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in interpalpebral fissure during the blink
Time Frame: Video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
|
Video analysis to measure the completeness of eye closure with the MLP compared to 1) no device, 2) relative to the contralateral side (if normal), 3) relative to different configurations of the device and custom vs. non-custom frames.
|
Video recording will be performed 7 times for the duration of the study (4 videos performed during visit 1; 3 video performed during visit 2)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kevin Houston, OD, M. Sc., Mass Eye and Ear
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Eye Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Eyelid Diseases
- Brain Injuries
- Brain Injuries, Traumatic
- Myasthenia Gravis
- Blepharoptosis
Other Study ID Numbers
- 18-166H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
Clinical Trials on Magnetic Levator Prosthesis (MLP)
-
Massachusetts Eye and Ear InfirmaryNational Eye Institute (NEI)RecruitingStroke | Myasthenia Gravis | Traumatic Brain Injury | Chronic Progressive External Ophthalmoplegia | Ptosis, Eyelid | BlepharoptosisUnited States
-
Kevin HoustonCompletedBlepharoptosis | Facial Paralysis | LagophthalmosUnited States