Management of Severe Congenital Blepharoptosis

December 31, 2019 updated by: Mohamed Farag Khalil Ibrahiem, Minia University

Evaluation of Polytetrafluoroethylene (Ptose-up) in Management of Severe Congenital Blepharoptosis

Frontalis sling surgery was carried out using Ptose-up under general anaesthesia for patients with severe congenital ptosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Frontalis sling surgery was carried out using Ptose-up for patients with severe congenital ptosis in 23 eyes of 15 patients and they followed up for at least 6 months to detect the success rate and if there is any postoperative complications.

Study Type

Interventional

Enrollment (Actual)

15

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
    • Minia
      • Minya, Minia, Egypt, 61111
        • Faculty of medicine

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

11 months to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe congenital blepharoptosis
  • Poor levator muscle function
  • No previous ptosis surgery

Exclusion Criteria:

  • Patients with Jaw winking phenomenon
  • Blepharophimosis syndrome
  • Congenital myasthenia

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: severe congenital ptosis
Patients with severe congenital ptosis with poor levator muscle function
Procedure: Ptosis surgery
Frontalis sling surgery using pose-up and Wright's fascia-lata needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of ptosis
Time Frame: 3 months
The average marginal reflex distance was improved from -0.8 mm preoperative to +2.73 mm after 3 months
3 months

Collaborators and Investigators

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

Sponsor

Minia 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)

February 1, 2017

Primary Completion (Actual)

March 10, 2018

Study Completion (Actual)

September 17, 2018

Study Registration Dates

First Submitted

December 28, 2019

First Submitted That Met QC Criteria

December 28, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oculoplastic Unit

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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