Mild PtosisLidtuckingNCT04883853
A Newly Modified Technique for Levator Muscle Tucking in Blepharoptosis Surgery: An Egyptian Tertiary Center Study
A study testing Mild _moderate Ptosis tucking in people with Mild Ptosis and Moderate Ptosis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Mild to moderate blepharoptosis with good levator function is usually corrected by levator muscle resection or advancement with their modifications with high success rate. Levator plication technique has been strongly suggested in patients with mild to moderate ptosis, advocated by its simple and rapid recovery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Ptosis, Moderate Ptosis
- What is being tested?
- Mild _moderate Ptosis tucking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 20 Feb 2019
- 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 _moderate blepharoptosis
Who cannot join
- severe, traumatic, recurrent, or mechanical ptosis, third nerve palsy, Marcus-Gunn jaw winking syndrome, abnormal ocular motility, and absent Bell's phenomenon
Trial locations and contacts
1 site in 1 country.
About this study
Mild to moderate blepharoptosis with good levator function is usually corrected by levator muscle resection or advancement with their modifications with high success rate. Levator plication technique has been strongly suggested in patients with mild to moderate ptosis, advocated by its simple and rapid recovery. Its drawback is a high recurrence rate.
We suggest a modified tucking technique that improves the force of eyelid elevation with preserved normal anatomy of Muller's muscle and conjunctiva with less disturbance to the Levator muscle aponeurosis. It is a short procedure, less complications with good aesthetic results and high patient's satisfaction.
Read the detailed description
A prospective single-centre study enrolling 180 patients with blepharoptosis at Ain Shams University Hospitals from March 2017 to February 2019. Patients of unilateral or bilateral mild to moderate ptosis with good levator function (more than 8 mm) were included. Those with severe, traumatic, recurrent, mechanical ptosis, Marcus-Gunn jaw winking syndrome, third nerve palsy, absent Bell's phenomenon, or abnormal ocular motility were excluded. The follow-up was at one week, one month, three months, six months, and one year visits. Functional outcome was assessed by analysis of the upper eyelid margin position in relation to the superior limbus and classified as very good (2 mm), good (2-4 mm), poor (5 mm) and preoperative to postoperative difference in marginal reflex distance (MRD). The aesthetic outcome was assessed in the form of symmetry of eyelid height, lid contour, lid crease presence, and degree of patient's postoperative satisfaction.
- Conditions
- Mild Ptosis, Moderate Ptosis
- Being tested
- Mild _moderate Ptosis tucking
- Keywords
- Ptosis, plication, levator muscle, tucking.
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild _moderate Ptosis tuckingProcedure or surgery
A modified levator muscle tucking procedure.The level of sutures was determined according to the levator muscle function and the desired eyelid height. The middle (main) suture was taken first at the level of the medial part of the pupil and was tightened to keep the lid height at the superior limbus and the other two sutures (medial and lateral) were then adjusted. A spindle-shaped, horizontal part of the levator aponeurosis (2.5-3 mm wide and 0.5 mm deep) was excised at the site of insertion into the tarsus before tightening the central suture to induce strong fibrosis and adhesion between the tucked levator aponeurosis and the tarsus
| Study group | Role | What they receive |
|---|---|---|
| Mild -Moderate Ptosis with good levator function (more than 8 mm) | Experimental | The upper eyelid crease was marked for the incision site, up to 5-7 mm from the lid margin, guided by the fellow eyelid crease position. The skin incision was done and the orbicularis occuli muscle was dissected to the tarsus. The anterior surface of the tarsal plate was then identified with the aponeurosis at its insertion, the orbital septum was then opened with a resultant fat prolapse, and the levator aponeurosis exposed until Whitnall's ligament. Three double-armed 5/0 polyester white braided, non-absorbable sutures, with spatulated needle 1/4 circle (Astralen, Assut Medical Sàrl, Pully-Lausanne, Switzerland) were passed between the levator aponeurosis near Whitnall's ligament and the anterior surface of the tarsus in a mattress form Receives: Procedure: Mild _moderate Ptosis tucking |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative marginal reflex distance
Distance between upper lid margin and pen torch reflex
Measured: first day postoperative
Secondary outcomes (1)
upper eyelid margin position
margin position in relation to the superior limbus in the digital photos
Measured: first day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Mar 2017
- Primary completion1 Feb 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild PtosisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwa Ahmed, M.D,FRCS, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883853
- Sponsor's protocol ID
- S1
- Acronym
- Lidtucking
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Newly Modified Technique for Levator Muscle Tucking in Blepharoptosis Surgery: An Egyptian Tertiary Center Study
- ClinicalTrials.gov ID
- NCT04883853
- Acronym / sponsor ID
- Lidtucking / S1
- Conditions
- Mild Ptosis, Moderate Ptosis
- Keywords
- Ptosis, plication, levator muscle, tucking.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 12 May 2021 (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.
Mild to moderate blepharoptosis with good levator function is usually corrected by levator muscle resection or advancement with their modifications with high success rate. Levator plication technique has been strongly suggested in patients with mild to moderate ptosis, advocated by its simple and rapid recovery. Its drawback is a high recurrence rate.
We suggest a modified tucking technique that improves the force of eyelid elevation with preserved normal anatomy of Muller's muscle and conjunctiva with less disturbance to the Levator muscle aponeurosis. It is a short procedure, less complications with good aesthetic results and high patient's satisfaction.
Detailed description
A prospective single-centre study enrolling 180 patients with blepharoptosis at Ain Shams University Hospitals from March 2017 to February 2019. Patients of unilateral or bilateral mild to moderate ptosis with good levator function (more than 8 mm) were included. Those with severe, traumatic, recurrent, mechanical ptosis, Marcus-Gunn jaw winking syndrome, third nerve palsy, absent Bell's phenomenon, or abnormal ocular motility were excluded. The follow-up was at one week, one month, three months, six months, and one year visits. Functional outcome was assessed by analysis of the upper eyelid margin position in relation to the superior limbus and classified as very good (2 mm), good (2-4 mm), poor (5 mm) and preoperative to postoperative difference in marginal reflex distance (MRD). The aesthetic outcome was assessed in the form of symmetry of eyelid height, lid contour, lid crease presence, and degree of patient's postoperative satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild -Moderate Ptosis with good levator function (more than 8 mm) | Experimental | Procedure: Mild _moderate Ptosis tuckingThe upper eyelid crease was marked for the incision site, up to 5-7 mm from the lid margin, guided by the fellow eyelid crease position. The skin incision was done and the orbicularis occuli muscle was dissected to the tarsus. The anterior surface of the tarsal plate was then identified with the aponeurosis at its insertion, the orbital septum was then opened with a resultant fat prolapse, and the levator aponeurosis exposed until Whitnall's ligament. Three double-armed 5/0 polyester white braided, non-absorbable sutures, with spatulated needle 1/4 circle (Astralen, Assut Medical Sàrl, Pully-Lausanne, Switzerland) were passed between the levator aponeurosis near Whitnall's ligament and the anterior surface of the tarsus in a mattress form |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mild _moderate blepharoptosis
Key exclusion criteria (1 listed)
- severe, traumatic, recurrent, or mechanical ptosis, third nerve palsy, Marcus-Gunn jaw winking syndrome, abnormal ocular motility, and absent 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 |
|---|---|---|
| Mild _moderate Ptosis tuckingA modified levator muscle tucking procedure.The level of sutures was determined according to the levator muscle function and the desired eyelid height. The middle (main) suture was taken first at the level of the medial part of the pupil and was tightened to keep the lid height at the superior limbus and the other two sutures (medial and lateral) were then adjusted. A spindle-shaped, horizontal part of the levator aponeurosis (2.5-3 mm wide and 0.5 mm deep) was excised at the site of insertion into the tarsus before tightening the central suture to induce strong fibrosis and adhesion between the tucked levator aponeurosis and the tarsus | Procedure or surgery | Mild -Moderate Ptosis with good levator function (more than 8 mm) |
Primary outcome
post-operative marginal reflex distance
Time frame: first day postoperative
Distance between upper lid margin and pen torch reflex
1 secondary outcome
upper eyelid margin position
Time frame: first day postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
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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.
Marwa Ahmed, M.D,FRCS principal investigator
Ain Shams 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 Mild _moderate Ptosis tucking in people with Mild Ptosis and Moderate Ptosis, run by Ain Shams 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 1 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: finished, as of the sponsor's last update on 12 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative marginal reflex distance (time frame: first day postoperative). 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 12 May 2021.