Maldevelopment Of Levator Muscle And Its Aponeurosis In Simple Congenital Ptosis: Clinical, Surgical And Histopathological Analysis
Sponsor study identifier
interventional
153
1 country
1
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2026
Actual (reported)March 12, 2026
Actual (reported)April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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AssiuyU
Asyut, Egypt
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.
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.
Ahmad Awad Mohamed, MD
Assiut University
Dalia Mohamed, PROFESSOR
Assiut University
Zeiad Eldaly, MD
Assiut University
First Submitted
February 21, 2026
First Posted
March 12, 2026
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2028
Research on Precision Diagnosis and Treatment Decision of Common Eye Diseases Based on Artificial Intelligence
Contact the study team to confirm eligibility.
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.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 12, 2026
Record last verified: 2026-03
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