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

NCT ID: NCT04883853

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-02-20

Brief 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. 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.

Conditions

Mild Ptosis; Moderate Ptosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Mild _moderate Ptosis tucking

Intervention Type: PROCEDURE

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

Interventions

Mild _moderate Ptosis tucking

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marwa Ahmed, M.D,FRCS

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Faculty of medicine Ain Shams University

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

S1

Identifier Type: -

Identifier Source: org_study_id