Levator Muscle and Its Aponeurotic Maldevelopment in Congenital Ptosis

March 10, 2026 updated by: Abeer Abdel-Fattah Mohammed Ali, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Asyut, Egypt
        • AssiuyU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ptosis
Procedure: levator muscle resection

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nature and Pattern of Levator Muscle Dysgenesis
Time Frame: Preoperative 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.
Preoperative clinical assessment compared with histopathological findings obtained at time of surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ahmad Awad Mohamed, MD, Assiut University
  • Study Director: Dalia Mohamed, PROFESSOR, Assiut University
  • Study Director: Zeiad Eldaly, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 21, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • congenital ptosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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