Müller's Muscle as a New Proprioceptive Organ
1 other identifier
observational
50
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2018
CompletedFirst Posted
Study publicly available on registry
January 11, 2018
CompletedStudy Start
First participant enrolled
January 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2021
CompletedJanuary 11, 2018
January 1, 2018
2 years
January 5, 2018
January 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
presence of proprioceptive organs in the muller muscle
presence of proprioceptive organs in the muller muscle
2 years
Study Arms (1)
muller muscle
muller muscle and conjunctiva excised during muller muscle conjunctival resection
Interventions
fresh MM specimens from patients undergoing Müllerectomies will undergo histologic examinations
Eligibility Criteria
patients over 18 years old undergoing Müllerectomies
You may qualify if:
- specimens from patients undergoing Müllerectomies
You may not qualify if:
- small specimens (\<1 cm length and width)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba_Medical_Center
Ramat Gan, 52621, Israel
Related Publications (1)
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.
PMID: 15878076BACKGROUND
Biospecimen
specimens of muller muscle
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, oculoplastic unit
Study Record Dates
First Submitted
January 5, 2018
First Posted
January 11, 2018
Study Start
January 15, 2018
Primary Completion
January 15, 2020
Study Completion
January 15, 2021
Last Updated
January 11, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share