BlepharoptosisEarly Phase 1NCT04807855
Custom Print Megnetic Levator Prosthesis Pilot Comparison
A Early Phase 1 study testing The cMLP device in people with Blepharoptosis, run by Skelmet Inc at 1 site in United States.
Trial summary
Study the device feasibility of non-surgical treatment for blepharoptosis (inability to open the eyelid) consisting of a biocompatible magnetic element adhered to the upper eyelid and a second magnet above the eye on a custom 3D-printed eyeglasses frame with a dial to provide adjustable magnetic force to open the eye… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Blepharoptosis
- What is being tested?
- The cMLP device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 31 Mar 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of Blepharoptosis for at least one eye, 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. Sex - All. Gender Based - All.
Who cannot join
- Absence of Blepharoptosis. Age less than 5, Severe Cognitive impairment defined as Mini-mental score less than 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. Healthy Volunteers.
Trial locations and contacts
1 site in 1 country.
About this study
Study the device feasibility of non-surgical treatment for blepharoptosis (inability to open the eyelid) consisting of a biocompatible magnetic element adhered to the upper eyelid and a second magnet above the eye on a custom 3D-printed eyeglasses frame with a dial to provide adjustable magnetic force to open the eye while still allowing eye closure.
Read the detailed description
Extensive description of the study protocol is provided in the Research Strategy (R), but key components are summarized and justified here. This is a prospective, interventional, single-arm, single-group open label study. Because the primary objective of this study is to perform prototyping in the interest of developing and determining the feasibility of our novel approach, randomization to treatment or control is not necessary or appropriate at this stage. All participants will have ptosis and will be fitted with the experimental custom adjustable force MLP. Determining if the custom MLP is superior to the non-custom MLP is beyond the scope of this phase I SBIR project.
The primary outcome is custom MLP fitting success defined as 8mm interpalpebral fissure size or greater, patient desire to engage in a 20-min trial, and comfort rated greater than 5 out of 10 after the 20 minute trial (all criteria must be met). These criteria may be met at any one visit in the prototyping process. Therefore, one prototype may fail but if subsequent prototypes succeed, the case will be rated as a success. Selection of the criteria was based on a desire to have both objective and subjective metrics. Eye opening of 8mm was selected because it is a functional amount of eye opening found to be useful to patients in prior studies (note that these patients do not have inferior lid malposition). We have used interpalpebral fissure as a primary outcome as opposed to Marginal Reflex Distance (distance from the corneal reflection to upper lid) in order to allow enrollment of bilateral and severe cases, and to provide a common outcome for both eye opening and closing on the blink. Desire to engage in a 20-minute trial was selected as a criteria because it provides some information on the patient's opinion of the device. Comfort greater than 5 out of 10 indicates better than neutral, and was selected as a minimum goal for success (median comfort in our prior study was 8 out of 10).
The statistical analysis method for the primary outcome will be an exact binomial test of one proportion to determine which condition is met for more than half of patients. If the prototype approach is successful for greater than half of patients after 20 minutes of wear there will be a large enough sample for a phase II study to warrant continued development.
Sample Size Calculation for primary outcome: With 10 subjects we will have 80% power to show that the success rate significantly exceeds 50% with a one-sided alpha=0.05 exact binomial test of one proportion when the success rate is 8/10 or greater, meaning 8 would have to succeed to reach significance. With 15 subjects the success rate would need to be 11 to reach significance.
- Conditions
- Blepharoptosis
- Being tested
- The cMLP device
- Keywords
- Blepharoptosis
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cMLP deviceDevice
There is only one medical device we are testing, so only one intervention.
| Study group | Role | What they receive |
|---|---|---|
| the experimental arm | Experimental | All subjects, the ptosis group and the normal group receive the same intervention. Receives: Device: The cMLP device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting interpalpebral fissure size
Interpalpebral fissure is defined as the greatest distance between the upper and lower eye lid margins at the insertion point of the lashes. Resting is defined as point where the eyelid is maximally elevated.
Measured: after 20 minutes of wear
Patient decision to participate in a 20-min trial with the prototype MLP
This is a binary response measure (1 = yes I would like to participate or 0 = no I would not like to participate.
Measured: after 2 minutes of wear
Comfort rating scale
This measure is a 10 point likert-type rating scale used to quantify the comfort of the MLP (1 poor comfort to 10 high comfort).
Measured: after 20 minutes of wear
Secondary outcomes (3)
Difference in the resting interpalpebral fissure size from highest to lowest magnetic force settings
Interpalpebral fissure is defined as the greatest distance between the upper and lower eye lid margins at the insertion point of the lashes. Resting is defined as point where the eyelid is maximally elevated.
Measured: after 2 minutes of wear
Interpalpebral fissure size at maximum blink
Interpalpebral fissure is defined as the greatest distance between the upper and lower eye lid margins at the insertion point of the lashes. Maximum blink is the point of smallest interpalpebral fissure (most closing).
Measured: after 2 minutes, 20 minutes, and 1-week of wear
Frequency and severity of adverse events
Thresholds for adverse events include eyelid skin erythema greater than grade II on the industry scale, grade II worsening in corneal staining on the NEI industry scale, and a greater than 2-line worsening in visual acuity in the treated eye.
Measured: after 20 minutes and 1-week of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Apr 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skelmet Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Responsible party
- Sponsor
- Investigators
- Yu Cao, Mr, Principal investigator, Skelmet Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807855
- Sponsor's protocol ID
- Skelmet
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom Print Megnetic Levator Prosthesis Pilot Comparison
- ClinicalTrials.gov ID
- NCT04807855
- Acronym / sponsor ID
- Skelmet
- Conditions
- Blepharoptosis
- Keywords
- Blepharoptosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Skelmet IncIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study the device feasibility of non-surgical treatment for blepharoptosis (inability to open the eyelid) consisting of a biocompatible magnetic element adhered to the upper eyelid and a second magnet above the eye on a custom 3D-printed eyeglasses frame with a dial to provide adjustable magnetic force to open the eye while still allowing eye closure.
Detailed description
Extensive description of the study protocol is provided in the Research Strategy (R), but key components are summarized and justified here. This is a prospective, interventional, single-arm, single-group open label study. Because the primary objective of this study is to perform prototyping in the interest of developing and determining the feasibility of our novel approach, randomization to treatment or control is not necessary or appropriate at this stage. All participants will have ptosis and will be fitted with the experimental custom adjustable force MLP. Determining if the custom MLP is superior to the non-custom MLP is beyond the scope of this phase I SBIR project.
The primary outcome is custom MLP fitting success defined as 8mm interpalpebral fissure size or greater, patient desire to engage in a 20-min trial, and comfort rated greater than 5 out of 10 after the 20 minute trial (all criteria must be met). These criteria may be met at any one visit in the prototyping process. Therefore, one prototype may fail but if subsequent prototypes succeed, the case will be rated as a success. Selection of the criteria was based on a desire to have both objective and subjective metrics. Eye opening of 8mm was selected because it is a functional amount of eye opening found to be useful to patients in prior studies (note that these patients do not have inferior lid malposition). We have used interpalpebral fissure as a primary outcome as opposed to Marginal Reflex Distance (distance from the corneal reflection to upper lid) in order to allow enrollment of bilateral and severe cases, and to provide a common outcome for both eye opening and closing on the blink. Desire to engage in a 20-minute trial was selected as a criteria because it provides some information on the patient's opinion of the device. Comfort greater than 5 out of 10 indicates better than neutral, and was selected as a minimum goal for success (median comfort in our prior study was 8 out of 10).
The statistical analysis method for the primary outcome will be an exact binomial test of one proportion to determine which condition is met for more than half of patients. If the prototype approach is successful for greater than half of patients after 20 minutes of wear there will be a large enough sample for a phase II study to warrant continued development.
Sample Size Calculation for primary outcome: With 10 subjects we will have 80% power to show that the success rate significantly exceeds 50% with a one-sided alpha=0.05 exact binomial test of one proportion when the success rate is 8/10 or greater, meaning 8 would have to succeed to reach significance. With 15 subjects the success rate would need to be 11 to reach significance.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the experimental arm | Experimental | Device: The cMLP deviceAll subjects, the ptosis group and the normal group receive the same intervention. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of Blepharoptosis for at least one eye, 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. Sex - All. Gender Based - All.
Key exclusion criteria (1 listed)
- Absence of Blepharoptosis. Age less than 5, Severe Cognitive impairment defined as Mini-mental score less than 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. Healthy Volunteers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The cMLP deviceThere is only one medical device we are testing, so only one intervention. | Device | the experimental arm |
Primary outcome
Resting interpalpebral fissure size
Time frame: after 20 minutes of wear
Interpalpebral fissure is defined as the greatest distance between the upper and lower eye lid margins at the insertion point of the lashes. Resting is defined as point where the eyelid is maximally elevated.
Patient decision to participate in a 20-min trial with the prototype MLP
Time frame: after 2 minutes of wear
This is a binary response measure (1 = yes I would like to participate or 0 = no I would not like to participate.
Comfort rating scale
Time frame: after 20 minutes of wear
This measure is a 10 point likert-type rating scale used to quantify the comfort of the MLP (1 poor comfort to 10 high comfort).
3 secondary outcomes
Difference in the resting interpalpebral fissure size from highest to lowest magnetic force settings
Time frame: after 2 minutes of wear
Interpalpebral fissure size at maximum blink
Time frame: after 2 minutes, 20 minutes, and 1-week of wear
Frequency and severity of adverse events
Time frame: after 20 minutes and 1-week of wear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No. We will not be sharing IPD with other researchers.
Related trials for Blepharoptosis
RecruitingObservational study
Blepharoptosis After Repeated Intravitreal Anti-VEGF Injections: A Prospective Study
Blepharoptosis, Age-Related Macular Degeneration
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Not yet recruiting
Effect of Suture Material on Eyelid Height Stability After Anterior White-Line Advancement for Aponeurotic Ptosis.
Blepharoptosis
Active, not recruitingObservational study
Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients With Mild to Moderate Facial Ptosis.
Ptosis, Ptosis, Mild
Recruiting
A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis
Blepharoptosis, Device Usability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Cao, Mr principal investigator
Skelmet Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing The cMLP device in people with Blepharoptosis, run by Skelmet Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting interpalpebral fissure size (time frame: after 20 minutes of wear). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.