Back to resultsManagement of Severe Congenital Blepharoptosis
Primary Purpose
Blepharoptosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ptosis surgery
Sponsored by
About this trial
This is an interventional treatment trial for Blepharoptosis
Eligibility Criteria
Inclusion Criteria:
- Severe congenital blepharoptosis
- Poor levator muscle function
- No previous ptosis surgery
Exclusion Criteria:
- Patients with Jaw winking phenomenon
- Blepharophimosis syndrome
- Congenital myasthenia
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
severe congenital ptosis
Arm Description
Patients with severe congenital ptosis with poor levator muscle function
Outcomes
Primary Outcome Measures
Improvement of ptosis
The average marginal reflex distance was improved from -0.8 mm preoperative to +2.73 mm after 3 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04214379
Brief Title
Management of Severe Congenital Blepharoptosis
Official Title
Evaluation of Polytetrafluoroethylene (Ptose-up) in Management of Severe Congenital Blepharoptosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 10, 2018 (Actual)
Study Completion Date
September 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Frontalis sling surgery was carried out using Ptose-up under general anaesthesia for patients with severe congenital ptosis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
severe congenital ptosis
Arm Type
Other
Arm Description
Patients with severe congenital ptosis with poor levator muscle function
Intervention Type
Procedure
Intervention Name(s)
Ptosis surgery
Intervention Description
Frontalis sling surgery using pose-up and Wright's fascia-lata needle
Primary Outcome Measure Information:
Title
Improvement of ptosis
Description
The average marginal reflex distance was improved from -0.8 mm preoperative to +2.73 mm after 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Months
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe congenital blepharoptosis
Poor levator muscle function
No previous ptosis surgery
Exclusion Criteria:
Patients with Jaw winking phenomenon
Blepharophimosis syndrome
Congenital myasthenia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed F Ibrahiem, MD
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Management of Severe Congenital Blepharoptosis
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