A Newly Modified Technique for Levator Muscle Tucking in Blepharoptosis Surgery: An Egyptian Tertiary Center Study (Lidtucking)

May 7, 2021 updated by: Ain Shams University

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

Completed

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11566
        • Faculty of medicine Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marwa Ahmed, M.D,FRCS, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 20, 2019

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mild Ptosis

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