Congenital PtosisNCT05895695
Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
A study testing levator muscle resection and levator muscle plication in people with Congenital Ptosis, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis. 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 and levator muscle plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2023to Feb 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- mild to moderate simple unilateral congenital ptosis with good to fair levator function
Who cannot join
- severe ptosis
- poor levator function
- poor Bell's phenomenon
- lagophthalmos
- diminished corneal sensation
- completed congenital or acquired ptosis
- history of previous lid surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levator Muscle Resection for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
The aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis.
Read the detailed description
Blepharotosis is one of the most encountered oculoplastic problems. Blepharoptosis is an abnormal low lying upper eyelid margin more than 2mm below the superior corneal limbus in the primary gaze position.
It can be subdivided according to the amount of levator function into poor (0-5),fair (6-11) or good (12 or more) millimeter. It can be classified also according to the degree of ptosis into mild (2mm) moderate (3mm) and severe ( 4mm or more). Surgical options for each of these groups are based on levator function as well as the degree and the cause of ptosis.
- Conditions
- Congenital Ptosis
- Being tested
- levator muscle resection, levator muscle plication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levator muscle resectionProcedure or surgery
resection of levator muscle in congenital unilateral ptosis
levator muscle plicationProcedure or surgery
plication of levator muscle in congenital unilateral ptosis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | evaluation of levator muscle resection on congenital ptosis Receives: Procedure: levator muscle resection |
| 2 | Active comparator | evaluation of levator muscle plication on congenital ptosis Receives: Procedure: levator muscle plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of outcome of levator muscle resection and plication in mild to moderate congenital ptosis
Comparison of surgical efficacy of levator muscle resection and plication regarding lid height as measured by MRD 1
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (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 Sohag 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maggi Hosam Wasily, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895695
- Sponsor's protocol ID
- Soh-Med-23-03-01MS
- Status last verified
- Jun 2023
- First submitted
- 11 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
SooHoo JR, Davies BW, Allard FD, Durairaj VD. Congenital ptosis. Surv Ophthalmol. 2014 Sep-Oct;59(5):483-92. doi: 10.1016/j.survophthal.2014.01.005. Epub 2014 Feb 5.
PubMed 24657037Nemet AY. Accuracy of Marginal Reflex Distance Measurements in Eyelid Surgery. J Craniofac Surg. 2015 Oct;26(7):e569-71. doi: 10.1097/SCS.0000000000001304.
PubMed 26468822Hwang K. Surgical anatomy of the upper eyelid relating to upper blepharoplasty or blepharoptosis surgery. Anat Cell Biol. 2013 Jun;46(2):93-100. doi: 10.5115/acb.2013.46.2.93. Epub 2013 Jun 30.
PubMed 23869256Baldwin 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 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levator Muscle Resection for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
- ClinicalTrials.gov ID
- NCT05895695
- Acronym / sponsor ID
- Soh-Med-23-03-01MS
- Conditions
- Congenital Ptosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 8 Jun 2023 (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.
The aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis.
Detailed description
Blepharotosis is one of the most encountered oculoplastic problems. Blepharoptosis is an abnormal low lying upper eyelid margin more than 2mm below the superior corneal limbus in the primary gaze position.
It can be subdivided according to the amount of levator function into poor (0-5),fair (6-11) or good (12 or more) millimeter. It can be classified also according to the degree of ptosis into mild (2mm) moderate (3mm) and severe ( 4mm or more). Surgical options for each of these groups are based on levator function as well as the degree and the cause of ptosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: levator muscle resectionevaluation of levator muscle resection on congenital ptosis |
| 2 | Active comparator | Procedure: levator muscle plicationevaluation of levator muscle plication on congenital ptosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- mild to moderate simple unilateral congenital ptosis with good to fair levator function
Key exclusion criteria (7 listed)
- severe ptosis
- poor levator function
- poor Bell's phenomenon
- lagophthalmos
- diminished corneal sensation
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 resectionresection of levator muscle in congenital unilateral ptosis | Procedure or surgery | 1 |
| levator muscle plicationplication of levator muscle in congenital unilateral ptosis | Procedure or surgery | 2 |
Primary outcome
Comparison of outcome of levator muscle resection and plication in mild to moderate congenital ptosis
Time frame: 6 months
Comparison of surgical efficacy of levator muscle resection and plication regarding lid height as measured by MRD 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 24657037SooHoo JR, Davies BW, Allard FD, Durairaj VD. Congenital ptosis. Surv Ophthalmol. 2014 Sep-Oct;59(5):483-92. doi: 10.1016/j.survophthal.2014.01.005. Epub 2014 Feb 5.
- Background: PubMed 26468822Nemet AY. Accuracy of Marginal Reflex Distance Measurements in Eyelid Surgery. J Craniofac Surg. 2015 Oct;26(7):e569-71. doi: 10.1097/SCS.0000000000001304.
- Background: PubMed 23869256Hwang K. Surgical anatomy of the upper eyelid relating to upper blepharoplasty or blepharoptosis surgery. Anat Cell Biol. 2013 Jun;46(2):93-100. doi: 10.5115/acb.2013.46.2.93. Epub 2013 Jun 30.
- Background: 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.
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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.
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 and levator muscle plication in people with Congenital Ptosis, run by Sohag 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 7 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 8 Jun 2023. 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 Maggi h Shaker, MBBCH (01286773334, magi_shaker@med.Sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of outcome of levator muscle resection and plication in mild to moderate congenital ptosis (time frame: 6 months). 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 NCT05895695, 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 8 Jun 2023.