Congenital PtosisNCT04537169
Clinical Significance of Whitnall Ligament Structure
An observational study of Congenital Ptosis, run by Menoufia University at 1 site in Egypt.
Trial summary
Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Congenital Ptosis
- What is being tested?
- Levator resection
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2020to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: patients with congenital ptosis
Who may be able to join
- Congenital ptosis
Who cannot join
- Previous ptosis surgery
- Non congenital ptosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ophthalmology Department, Menoufia University Hospital
Shibīn al Kawm, Menoufia
Hoda M El Sobky, PhD, 01210804240 ext. 0020, elsobky.hoda@yahoo.com
About this study
Official title: Clinical Significance of Whitnall Ligament Structure in Patients With Congenital Ptosis
Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.
Read the detailed description
The study will be a prospective obsevational study. It will include patients (2-16 years old) who will undergo levator resection for simple congenital ptosis correction in Ophthalmology Department of Menoufia University Hospital.
Patients will be divided into 3 groups, 15 patients in each. Group I for mild ptosis, Group II for moderate ptosis Group 3 for severe ptosis.
Exclusion criteria included any patients with previous ptosis or any eyelid surgery and patients with a non congenital ptosis.
Patients included in the study well be informed about the research and the surgical maneuver which will be used with full discussion of all details regarding the postoperative follow up and the potential complications. A written consent in Arabic will then be taken from the parents of the patients
Preoperative assessment will include Complete ophthalmological examination including; Margin to Reflex Distance 1 (MRD1), Vertical Fissure Height (VFH), Levator function (LF), and eyelid crease shape and position.
Intraoperative assessment will include Whitnall ligament structure assessment including:
- The level (the length from the insertion of the levator aponeurosis to Whitnall's ligament)
- Shape (definite band-like, weak string, undifferentiated)
- Tightness.
Postoperative assessment will be on scheduled visits at first week, one month, 3 months and 6 months postoperatively and will include MRD1, VFH, LF, and lagophthalmos measurements
Results will be documented and tabulated and statistically managed.
- Conditions
- Congenital Ptosis
- Being tested
- Levator resection
- Keywords
- Whitnall ligament, congenital ptosis, levator resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levator resectionProcedure or surgery
Eyelid crease incision Dissection of the levator aponeurosis to the level of Whitnall ligament. Assessment of the structure of Whitnal ligament. Resection of a calculated part of the aponsurosis. re-attachment of the aponeurosis to the tarsus Incision closure with crease formation
| Study group | Role | What they receive |
|---|---|---|
| Mild congenital ptosis | children with mild congenital ptosis Receives: Procedure: Levator resection | |
| Moderate congenital ptosis | children with moderate congenital ptosis Receives: Procedure: Levator resection | |
| Severe congenital ptosis | children with severe congenital ptosis Receives: Procedure: Levator resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of levator resection in relation to structure of Whitnall ligament
Relating the structure of the ligament with the degree of severity of ptosis by studying its position, shape and tightness in all cases during surgery
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start20 Aug 2020
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital PtosisStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh S. Mandour, Menoufia University
- Investigators
- Richard C Allen, Study chair, Department of Ophthalmology, Cullen Eye Institute,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537169
- Sponsor's protocol ID
- OPHTH2/2020
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Whitnall Ligament Structure in Patients With Congenital Ptosis
- ClinicalTrials.gov ID
- NCT04537169
- Acronym / sponsor ID
- OPHTH2/2020
- Conditions
- Congenital Ptosis
- Keywords
- Whitnall ligament, congenital ptosis, levator resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 3 Sep 2020 (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.
Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.
Detailed description
The study will be a prospective obsevational study. It will include patients (2-16 years old) who will undergo levator resection for simple congenital ptosis correction in Ophthalmology Department of Menoufia University Hospital.
Patients will be divided into 3 groups, 15 patients in each. Group I for mild ptosis, Group II for moderate ptosis Group 3 for severe ptosis.
Exclusion criteria included any patients with previous ptosis or any eyelid surgery and patients with a non congenital ptosis.
Patients included in the study well be informed about the research and the surgical maneuver which will be used with full discussion of all details regarding the postoperative follow up and the potential complications. A written consent in Arabic will then be taken from the parents of the patients
Preoperative assessment will include Complete ophthalmological examination including; Margin to Reflex Distance 1 (MRD1), Vertical Fissure Height (VFH), Levator function (LF), and eyelid crease shape and position.
Intraoperative assessment will include Whitnall ligament structure assessment including:
- The level (the length from the insertion of the levator aponeurosis to Whitnall's ligament)
- Shape (definite band-like, weak string, undifferentiated)
- Tightness.
Postoperative assessment will be on scheduled visits at first week, one month, 3 months and 6 months postoperatively and will include MRD1, VFH, LF, and lagophthalmos measurements
Results will be documented and tabulated and statistically managed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild congenital ptosis | – | Procedure: Levator resectionchildren with mild congenital ptosis |
| Moderate congenital ptosis | – | Procedure: Levator resectionchildren with moderate congenital ptosis |
| Severe congenital ptosis | – | Procedure: Levator resectionchildren with severe congenital ptosis |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients with congenital ptosis
Key inclusion criteria (1 listed)
- Congenital ptosis
Key exclusion criteria (2 listed)
- Previous ptosis surgery
- Non congenital ptosis
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 resectionEyelid crease incision Dissection of the levator aponeurosis to the level of Whitnall ligament. Assessment of the structure of Whitnal ligament. Resection of a calculated part of the aponsurosis. re-attachment of the aponeurosis to the tarsus Incision closure with crease formation | Procedure or surgery | Mild congenital ptosis, Moderate congenital ptosis, Severe congenital ptosis |
Primary outcome
Success of levator resection in relation to structure of Whitnall ligament
Time frame: An average of 1 year
Relating the structure of the ligament with the degree of severity of ptosis by studying its position, shape and tightness in all cases during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Richard C Allen study chair
Department of Ophthalmology, Cullen Eye Institute,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Ptosis, run by Menoufia 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 2 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameh S Mandour, M.D. (01113139138 ext. 0020, dr_ssmandour@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of levator resection in relation to structure of Whitnall ligament (time frame: An average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2020.