Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Primary Purpose
Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Levator Prosthesis (MLP)
Kinesiotape Frontalis Sling (KTFS)
Sponsored by
About this trial
This is an interventional treatment trial for Blepharoptosis
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Massachusetts Eye and EarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MLP first, KTFS second
KTFS first, MLP second
Arm Description
Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.
Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.
Outcomes
Primary Outcome Measures
Difference between MLP and KTFS in the change in interpalpebral fissure during opening and spontaneous blinking
Measurements of the interpalpebral fissure will be taken from video recordings of eye lid opening and closing when using each of the devices
Secondary Outcome Measures
Difference between MLP and KTFS in the changes in interpalpebral fissure during volitional blinking
Measurements of the interpalpebral fissure will be taken from video recordings of volitional eye lid closing when using each of the devices
Proportion of subjects selecting each device
Proportion of subjects selecting either the MLP, the KTFS or neither
Full Information
NCT ID
NCT04678115
First Posted
December 14, 2020
Last Updated
October 7, 2022
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT04678115
Brief Title
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Official Title
A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 18, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Eye Institute (NEI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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. If considered clinically appropriate, participants may be invited to continue using the preferred device for an additional two months with weekly follow ups to provide information about longer-term use of the intervention. Participants who are still using one of the devices at the end of the two months will be returned to clinical care and receive a study follow up (telephone call) after another 6 and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis, Stroke, Traumatic Brain Injury, Chronic Progressive External Ophthalmoplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MLP first, KTFS second
Arm Type
Experimental
Arm Description
Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.
Arm Title
KTFS first, MLP second
Arm Type
Experimental
Arm Description
Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.
Intervention Type
Device
Intervention Name(s)
Magnetic Levator Prosthesis (MLP)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Kinesiotape Frontalis Sling (KTFS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference between MLP and KTFS in the change in interpalpebral fissure during opening and spontaneous blinking
Description
Measurements of the interpalpebral fissure will be taken from video recordings of eye lid opening and closing when using each of the devices
Time Frame
Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after)
Secondary Outcome Measure Information:
Title
Difference between MLP and KTFS in the changes in interpalpebral fissure during volitional blinking
Description
Measurements of the interpalpebral fissure will be taken from video recordings of volitional eye lid closing when using each of the devices
Time Frame
Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after)
Title
Proportion of subjects selecting each device
Description
Proportion of subjects selecting either the MLP, the KTFS or neither
Time Frame
At the end of the one-week period of home use of the second device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Houston, OD MSc
Phone
617-573-4177
Email
Kevin_Houston@meei.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sheryl Erwin, BS
Phone
617-573-6533
Email
sheryl_erwin@meei.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Houston, OD MSc
Organizational Affiliation
Massachusetts Eye and Ear
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Houston, OD MSc
Phone
617-573-4177
Email
kevin_houston@meei.harvard.edu
First Name & Middle Initial & Last Name & Degree
Sheryl Erwin, BS
Phone
617-573-6533
Email
sheryl_erwin@meei.harvard.edu
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
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