Eyelid Movement DisordersNCT03396627
Müller's Muscle as a New Proprioceptive Organ
An observational study of Eyelid Movement Disorders and Eyelid Ptosis Congenital, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Objectives: Upper eyelid retraction was believed to be maintained solely by voluntary contraction of the levator palpebrae superioris (LPS) and frontalis muscles, together with involuntary contraction of the sympathetically innervated Müller's muscle (MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eyelid Movement Disorders, Eyelid Ptosis Congenital
- What is being tested?
- pathological examination
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jan 2018to 15 Jan 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients over 18 years old undergoing Müllerectomies
Who may be able to join
- specimens from patients undergoing Müllerectomies
Who cannot join
- small specimens (<1 cm length and width)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Müller's Muscle as a New Proprioceptive Organ Evidence From Immunohistochemical Staining and Electron Microscopy to Verify That the Upper Eyelid Müller's Muscle Contains Proprioceptive Innervation for Reflexive Correction of Eyelid Position
Objectives: Upper eyelid retraction was believed to be maintained solely by voluntary contraction of the levator palpebrae superioris (LPS) and frontalis muscles, together with involuntary contraction of the sympathetically innervated Müller's muscle (MM). However, several studies have suggested that the LPS also undergoes involuntary contractions, and that a visual stimulus may not be the only trigger for frontalis muscle contractions. Recent studies hypothesized that the MM contains proprioceptive neuronal structures, which elicit involuntary LPS muscle contraction by the mesencephalic trigeminal nucleus via a continuous stretch reflex. We aim to identify proprioceptive structures in MM by means of histological examinations.
Methodology: Prospective study. Collaboration of oculoplastics, ophthalmologists and a neuroanatomy specialist in Sheba Medical Center. 50 fresh MM specimens from patients undergoing Müllerectomies will undergo histologic examinations, including immunohistochemical staining and light and electron microscopy.
Significance: Identification of proprioceptive structures in MM will be the first evidence-based proof of a proprioceptive mechanism in the eyelid. This might have a significant impact on future surgical management of eyelid procedures. Comprehensive understanding of the mechanisms underlying eyelid function is especially important in the management of children with ptosis who may have coexisting amblyopia.
Read the detailed description
The investigators' goal is to find proprioceptive neuronal structures in Müller's muscle (MM). The investigatorswill recruit 50 MM specimens of patients diagnosed with either unilateral or bilateral ptosis who were referred to undergo a posterior approach surgical correction (MMCR). In this surgical approach, the proximal part of MM is removed between the levator palpebrae superioris muscle and the tarsus of the upper eyelids. The excised tissue is generally not used but simply discarded. For study purposed, the investigators will obtain the patients' consent to save these tissues and carry out histologic examinations of the samples. No change in the surgical procedure or the following management will be needed.
- Being tested
- pathological examination
- Keywords
- eyelid, Muller
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pathological examinationDiagnostic test
fresh MM specimens from patients undergoing Müllerectomies will undergo histologic examinations
| Study group | Role | What they receive |
|---|---|---|
| muller muscle | muller muscle and conjunctiva excised during muller muscle conjunctival resection Receives: Diagnostic Test: pathological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of proprioceptive organs in the muller muscle
presence of proprioceptive organs in the muller muscle
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start15 Jan 2018 (estimated)
- Primary completion15 Jan 2020 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eyelid Movement DisordersStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Guy Ben-Simon, MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396627
- Sponsor's protocol ID
- 4384-17-SMC
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2018
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ben Simon GJ, Blaydon SM, Schwarcz RM, Nakra T, Goldberg RA, McCann JD. Paradoxical use of frontalis muscle and the possible role of botulinum a toxin in permanent motor relearning. Ophthalmology. 2005 May;112(5):918-22. doi: 10.1016/j.ophtha.2005.01.004.
PubMed 15878076
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Müller's Muscle as a New Proprioceptive Organ Evidence From Immunohistochemical Staining and Electron Microscopy to Verify That the Upper Eyelid Müller's Muscle Contains Proprioceptive Innervation for Reflexive Correction of Eyelid Position
- ClinicalTrials.gov ID
- NCT03396627
- Acronym / sponsor ID
- 4384-17-SMC
- Keywords
- eyelid, Muller
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 11 Jan 2018 (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.
Objectives: Upper eyelid retraction was believed to be maintained solely by voluntary contraction of the levator palpebrae superioris (LPS) and frontalis muscles, together with involuntary contraction of the sympathetically innervated Müller's muscle (MM). However, several studies have suggested that the LPS also undergoes involuntary contractions, and that a visual stimulus may not be the only trigger for frontalis muscle contractions. Recent studies hypothesized that the MM contains proprioceptive neuronal structures, which elicit involuntary LPS muscle contraction by the mesencephalic trigeminal nucleus via a continuous stretch reflex. We aim to identify proprioceptive structures in MM by means of histological examinations.
Methodology: Prospective study. Collaboration of oculoplastics, ophthalmologists and a neuroanatomy specialist in Sheba Medical Center. 50 fresh MM specimens from patients undergoing Müllerectomies will undergo histologic examinations, including immunohistochemical staining and light and electron microscopy.
Significance: Identification of proprioceptive structures in MM will be the first evidence-based proof of a proprioceptive mechanism in the eyelid. This might have a significant impact on future surgical management of eyelid procedures. Comprehensive understanding of the mechanisms underlying eyelid function is especially important in the management of children with ptosis who may have coexisting amblyopia.
Detailed description
The investigators' goal is to find proprioceptive neuronal structures in Müller's muscle (MM). The investigatorswill recruit 50 MM specimens of patients diagnosed with either unilateral or bilateral ptosis who were referred to undergo a posterior approach surgical correction (MMCR). In this surgical approach, the proximal part of MM is removed between the levator palpebrae superioris muscle and the tarsus of the upper eyelids. The excised tissue is generally not used but simply discarded. For study purposed, the investigators will obtain the patients' consent to save these tissues and carry out histologic examinations of the samples. No change in the surgical procedure or the following management will be needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| muller muscle | – | Diagnostic Test: pathological examinationmuller muscle and conjunctiva excised during muller muscle conjunctival resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients over 18 years old undergoing Müllerectomies
Key inclusion criteria (1 listed)
- specimens from patients undergoing Müllerectomies
Key exclusion criteria (1 listed)
- small specimens (<1 cm length and width)
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 |
|---|---|---|
| pathological examinationfresh MM specimens from patients undergoing Müllerectomies will undergo histologic examinations | Diagnostic test | muller muscle |
Primary outcome
presence of proprioceptive organs in the muller muscle
Time frame: 2 years
presence of proprioceptive organs in the muller muscle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Background: PubMed 15878076Ben Simon GJ, Blaydon SM, Schwarcz RM, Nakra T, Goldberg RA, McCann JD. Paradoxical use of frontalis muscle and the possible role of botulinum a toxin in permanent motor relearning. Ophthalmology. 2005 May;112(5):918-22. doi: 10.1016/j.ophtha.2005.01.004.
- Individual participant dataSharing planned: No
Related trials for Eyelid Movement Disorders
RecruitingPhase 2
DaxibotulinumtoxinA for Blepharospasm
Blepharospasm of Both Eyelids, Blepharospasm of Left Eyelid
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eyelid Movement Disorders and Eyelid Ptosis Congenital, run by Sheba Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 11 Jan 2018. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
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?
presence of proprioceptive organs in the muller muscle (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396627, which also lists 1 linked publication.
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 11 Jan 2018.