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Levator Muscle and Its Aponeurotic Maldevelopment in Congenital Ptosis

Maldevelopment Of Levator Muscle And Its Aponeurosis In Simple Congenital Ptosis: Clinical, Surgical And Histopathological Analysis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07466706
Enrollment
153
Registered
2026-03-12
Start date
2026-04-01
Completion date
2028-12-31
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Ptosis

Keywords

levator muscle

Brief summary

this study reports the incidence of levator muscle dysgenesis among patients with simple congenital myogenic ptosis. In addition, the study aims to describ the nature of the dysgenesis, including the gross appearance of the muscle intraoperatively as well as the histopathological features under the microscope, correlation between the degree of dysgenesis and the preoperative ptosis assessment, and evaluation of the surgical outcome after levator muscle resection. Also, this research aims to shed light on the role of aponeurotic developmental anomalies, specifically fibrotic changes and maldevelopment in the pathogenesis of simple congenital ptosis.

Detailed description

Despite the general agreement on the myogenic etiology of simple congenital ptosis, the exact pathogenesis of the levator palpebrae superioris (LPS) muscle remains controversial. This debate stems from confusing pathological changes within the LPS; while childhood ptosis is commonly attributed to muscle dystrophy , other reports have identified criteria consistent with dysgenesis. Consequently, the majority of published literature has focused on these muscle belly changes-supporting either the dysgenesis or dystrophy theories-or on neural etiologies in cases associated with superior rectus paresis or the Marcus Gunn jaw-winking phenomenon. However, congenital ptosis may also arise from mechanical or aponeurotic factors which are frequently overlooked. Aponeurotic disinsertion or dehiscence is a well-recognized cause of acquired (involutional or traumatic) ptosis and is classically corrected by the repair technique first described by Quickert. While typically associated with adults, congenital aponeurotic defects do exist; Anderson and Gordy attributed these to a failure of the levator aponeurosis (LA) to correctly insert into the tarsus. Despite this, reports exploring LA fibrotic changes in congenital cases remain scarce. Congenital aponeurotic maldevelopment is an estab- lished yet underreported entity of congenital ptosis. It could be suspected clinically with high crease position, lower lid position on downgaze and presence of corneal hue. The investigators have observed fibrotic changes within the LA, or fibrous bands anchoring the LA to surrounding structures, during resection in patients with simple congenital ptosis.

Interventions

All patients will undergo levator muscle resection under general anesthesia. A standard skin incision will be made through the eyelid crease and orbicularis muscle. The orbital septum will be opened to expose the preaponeurotic fat, which will be retracted to identify the Levator Aponeurosis (LA), Whitnall's ligament, and the Levator Palpebrae Superioris (LPS) muscle belly. * Macroscopic Assessment: Before resection, the LA and surrounding tissues will be meticulously inspected and photographed. We will document: 1. Fibrotic Changes 2. Aponeurotic Defects 3. LPS Characteristics 4. Whitnall's Ligament * Surgical Repair: Levator resection will be performed based on the degree of ptosis and levator function (utilizing Beard's tables or Berke's formula). In cases of aponeurotic dehiscence, the identified aponeurosis will be advanced and reattached to the anterior surface of the tarsus using double-armed 5-0 polyester sutures.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Unilateral or bilateral simple congenital ptosis

Exclusion criteria

* Previous eyelid or orbital surgery. * Acquired ptosis (traumatic, myogenic, or neurogenic). * Complex congenital ptosis (e.g., Marcus Gunn jaw-winking phenomenon, Blepharophimosis syndrome). * Poor or inverted Bell's phenomenon

Design outcomes

Primary

MeasureTime frameDescription
Nature and Pattern of Levator Muscle DysgenesisPreoperative clinical assessment compared with histopathological findings obtained at time of surgery.Characterization of gross intraoperative findings (fibrosis, fatty infiltration, aponeurotic abnormalities) and microscopic histopathological features across proximal, middle, and distal muscle segments. Distribution and predominance of abnormalities will be documented.

Countries

Egypt

Contacts

CONTACTAbeer Mohammed Ali, master MSc
abeerabdelfattah1@yahoo.com+201064464974
STUDY_DIRECTORAhmad Awad Mohamed, MD

Assiut University

STUDY_DIRECTORDalia Mohamed, PROFESSOR

Assiut University

STUDY_DIRECTORZeiad Eldaly, MD

Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026