Congenital PtosisNCT07466706
Levator Muscle and Its Aponeurotic Maldevelopment in Congenital Ptosis
A study testing levator muscle resection in people with Congenital Ptosis, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Ptosis
- What is being tested?
- levator muscle resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unilateral or bilateral simple congenital ptosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Ptosis
- Being tested
- levator muscle resection
- Keywords
- levator muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levator muscle resectionProcedure or 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:
- Fibrotic Changes
- Aponeurotic Defects
- LPS Characteristics
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ptosis | Active comparator | Not described Receives: Procedure: levator muscle resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative clinical assessment compared with histopathological findings obtained at time of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital PtosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Abdel-Fattah Mohammed Ali, Assiut University
- Investigators
- Ahmad Awad Mohamed, MD, Study director, Assiut UniversityDalia Mohamed, PROFESSOR, Study director, Assiut UniversityZeiad Eldaly, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466706
- Sponsor's protocol ID
- congenital ptosis
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 38429587Al-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.
PubMed 33156145Alahmadawy 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.
PubMed 40856211Baldwin 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.
PubMed 12142765
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maldevelopment Of Levator Muscle And Its Aponeurosis In Simple Congenital Ptosis: Clinical, Surgical And Histopathological Analysis
- ClinicalTrials.gov ID
- NCT07466706
- Acronym / sponsor ID
- congenital ptosis
- Conditions
- Congenital Ptosis
- Keywords
- levator muscle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ptosis | Active comparator | Procedure: levator muscle resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral or bilateral simple congenital ptosis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levator muscle resectionAll 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. | Procedure or surgery | ptosis |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication: PubMed 38429587Alahmadawy 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.
- Results publication: PubMed 33156145Al-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.
- Results publication: PubMed 40856211Alahmadawy 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.
- Results publication: PubMed 12142765Baldwin 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmad Awad Mohamed, MD study director
Assiut University
Dalia Mohamed, PROFESSOR study director
Assiut University
Zeiad Eldaly, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levator muscle resection in people with Congenital Ptosis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abeer Mohammed Ali, master MSc (+201064464974 ext. +201096083988, abeerabdelfattah1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature and Pattern of Levator Muscle Dysgenesis (time frame: Preoperative clinical assessment compared with histopathological findings obtained at time of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466706, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.