Surgical Management of Blepharoptosis

May 10, 2017 updated by: Noha Ali Essameldeen Mohamed Ali, Assiut University

Fixed Versus Adjustable Sutures in Management of Blepheroptosis

Comparison of the results of levator resection operation with the use of fixed sutures technique in which the levator muscle is approached through skin incision and the muscle shortened and sutured directly to the tarsus then the skin crease reformed with interrupted sutures which pick up the underlying levator muscle versus the results with the use of adjustable sutures in which the suture passes through the levator muscle into the tarsal plate and out through the skin edge .the skin crease is formed separately so that adjusting the suture doesn't open the wound, the suture can be adjusted according to the result up to 4 days post operative.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • Egypt
      • Assuit, Egypt, 71515
        • Assuit University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Cases of blepharoptosis admitted at Assiut University Hospital.
  • Cases that are fit for surgery.

Exclusion criteria:

  • Cases not fit for surgery.
  • Cases of pseudoptosis may result from many conditions that simulate an asymmetry of the upper eyelid level. Dysthyroid ophthalmopathy, enophthalmos, or exophthalmos can accentuate a minimal blepharoptosis or produce the appearance of blepharoptosis on the contralateral normal side,
  • Cases with diseases, such as myasthenia gravis; negativity for Bell palsy symptoms; and Marcus Gunn jaw-winking syndrome.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fixed suture
Procedure: levator muscle resection with fixed sutures technique
The levator muscle is approached through skin incision and the muscle shortened and sutured directly to the tarsus then the skin crease reformed with interrupted sutures which pick up the underlying levator muscle
Experimental: Adjustable suture
Procedure: Levator muscle resection with adjustable sutures technique
The adjustable sutures technique in which the sutures passes through the levator muscle into the tarsal plate and out through the skin edge .the skin crease is formed separately so that adjusting the suture doesn't open the wound, the suture can be adjusted according to the result up to 4 days post operative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cosmetic appearance
Time Frame: One week
Symmetry of the two eyelids was calculated based on the difference in the margin reflex distance between them in the primary position of gaze. The results were classified into good, fair, and poor
One week

Collaborators and Investigators

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

Sponsor

Assiut 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 (Anticipated)

March 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7540

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 Blepharoptosis

Clinical Trials on levator muscle resection with fixed sutures technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe