An observational study in Eyelid Movement Disorders and Eyelid Ptosis Congenital, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-11.
Sponsored by Sheba Medical Center · Observational
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.
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.
75 studies on the registry are indexed under Blepharoptosis; 14 are open to participants now.
This study's planned enrollment of 50 is below the median of 57 across 16 observational studies indexed under Blepharoptosis.
Browse Blepharoptosis studies →Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients over 18 years old undergoing Müllerectomies
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
muller muscle and conjunctiva excised during muller muscle conjunctival resection
Diagnostic Test: pathological examination
fresh MM specimens from patients undergoing Müllerectomies will undergo histologic examinations
presence of proprioceptive organs in the muller muscle
presence of proprioceptive organs in the muller muscle
Time frame: 2 years
Plan to share: No
Start is estimated for Jan 2018; primary completion for Jan 2020, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.