NCT07466706

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.

Trial Health

63
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Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress4%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

February 21, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

February 21, 2026

Last Update Submit

March 10, 2026

Conditions

Congenital Ptosis

Keywords

levator muscle

Outcome Measures

Primary Outcomes (1)

  • Nature and Pattern of Levator Muscle Dysgenesis

    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.

Study Arms (1)

ptosis

ACTIVE COMPARATOR
Procedure: levator muscle resection

Interventions

levator muscle resectionPROCEDURE

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.

ptosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral or bilateral simple congenital ptosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssiuyU

Asyut, Egypt

Location

Related Publications (4)

  • Alahmadawy YA, Ahmed RA. Congenital ptosis with aponeurotic maldevelopment: clinical and surgical perspectives : Aponeurotic maldevelopment in congenital ptosis. Int Ophthalmol. 2024 Mar 2;44(1):123. doi: 10.1007/s10792-024-03053-5.

    PMID: 38429587RESULT

  • Al-Faky YH. Surgical Observations of the Levator Aponeurosis Fibrotic Changes in Simple Congenital Ptosis Suggest Complex Pathogenesis. Ophthalmic Plast Reconstr Surg. 2021 Jul-Aug 01;37(4):329-333. doi: 10.1097/IOP.0000000000001860.

    PMID: 33156145RESULT

  • Alahmadawy YA, Ahmed RA, Allen RC, Diab MM. Levator Muscle Complex Exploration During Surgery for Simple Severe Congenital Ptosis. Ophthalmic Plast Reconstr Surg. 2026 Jan-Feb 01;42(1):90-96. doi: 10.1097/IOP.0000000000003015. Epub 2025 Aug 26.

    PMID: 40856211RESULT

  • Baldwin HC, Manners RM. Congenital blepharoptosis: a literature review of the histology of levator palpebrae superioris muscle. Ophthalmic Plast Reconstr Surg. 2002 Jul;18(4):301-7. doi: 10.1097/01.IOP.0000021973.72318.07.

    PMID: 12142765RESULT

Study Officials

  • Ahmad Awad Mohamed, MD

    Assiut University

    STUDY DIRECTOR

  • Dalia Mohamed, PROFESSOR

    Assiut University

    STUDY DIRECTOR

  • Zeiad Eldaly, MD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Abeer Mohammed Ali, master MSc

CONTACT

+201064464974abeerabdelfattah1@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc in Ophthalmology

Study Record Dates

First Submitted

February 21, 2026

First Posted

March 12, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations

EG(1)