NCT03396627

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

January 5, 2018

Last Update Submit

January 5, 2018

Conditions

Keywords

eyelidMuller

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

Diagnostic Test: pathological examination

Interventions

fresh MM specimens from patients undergoing Müllerectomies will undergo histologic examinations

muller muscle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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

Retention: SAMPLES WITHOUT DNA

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

Locations