Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
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| ClinicalTrials.gov Identifier: NCT04678115 |
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Recruitment Status :
Recruiting
First Posted : December 21, 2020
Last Update Posted : October 10, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Blepharoptosis Ptosis, Eyelid Myasthenia Gravis Stroke Traumatic Brain Injury Chronic Progressive External Ophthalmoplegia | Device: Magnetic Levator Prosthesis (MLP) Device: Kinesiotape Frontalis Sling (KTFS) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis |
| Actual Study Start Date : | June 1, 2021 |
| Estimated Primary Completion Date : | May 18, 2023 |
| Estimated Study Completion Date : | July 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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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. Device: 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. |
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Experimental: 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.
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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. Device: 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. |
- Difference between MLP and KTFS in the change in interpalpebral fissure during opening and spontaneous blinking [ Time Frame: Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) ]Measurements of the interpalpebral fissure will be taken from video recordings of eye lid opening and closing when using each of the devices
- Difference between MLP and KTFS in the changes in interpalpebral fissure during volitional blinking [ Time Frame: Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) ]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 [ Time Frame: At the end of the one-week period of home use of the second device ]Proportion of subjects selecting either the MLP, the KTFS or neither
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678115
| Contact: Kevin Houston, OD MSc | 617-573-4177 | Kevin_Houston@meei.harvard.edu | |
| Contact: Sheryl Erwin, BS | 617-573-6533 | sheryl_erwin@meei.harvard.edu |
| United States, Massachusetts | |
| Massachusetts Eye and Ear | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Kevin Houston, OD MSc 617-573-4177 kevin_houston@meei.harvard.edu | |
| Contact: Sheryl Erwin, BS 617-573-6533 sheryl_erwin@meei.harvard.edu | |
| Principal Investigator: | Kevin Houston, OD MSc | Massachusetts Eye and Ear |
| Responsible Party: | Kevin Houston, Assistant Professor, Massachusetts Eye and Ear Infirmary |
| ClinicalTrials.gov Identifier: | NCT04678115 |
| Other Study ID Numbers: |
2019P003055 R01EY029437 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 21, 2020 Key Record Dates |
| Last Update Posted: | October 10, 2022 |
| Last Verified: | October 2022 |
| 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 |
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Myasthenia Gravis Ophthalmoplegia, Chronic Progressive External Brain Injuries Brain Injuries, Traumatic Ophthalmoplegia Blepharoptosis Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Neoplasms by Site |
Neoplasms Paraneoplastic Syndromes Autoimmune Diseases of the Nervous System Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases Eyelid Diseases Eye Diseases Ocular Motility Disorders Cranial Nerve Diseases Paralysis Neurologic Manifestations Mitochondrial Myopathies |