- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883853
A Newly Modified Technique for Levator Muscle Tucking in Blepharoptosis Surgery: An Egyptian Tertiary Center Study (Lidtucking)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11566
- Faculty of medicine Ain shams university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mild _moderate blepharoptosis
Exclusion Criteria:
- severe, traumatic, recurrent, or mechanical ptosis, third nerve palsy, Marcus-Gunn jaw winking syndrome, abnormal ocular motility, and absent Bell's phenomenon
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mild -Moderate Ptosis with good levator function (more than 8 mm)
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post-operative marginal reflex distance
Time Frame: first day postoperative
|
Distance between upper lid margin and pen torch reflex
|
first day postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
upper eyelid margin position
Time Frame: first day postoperative
|
margin position in relation to the superior limbus in the digital photos
|
first day postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marwa Ahmed, M.D,FRCS, Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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