Management of Severe Congenital Blepharoptosis

Blepharoptosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214379
• Other study ID #: Oculoplastic Unit
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: September 17, 2018

Study information

• Verified date: December 2019
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 17, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Months to 9 Years

Eligibility

Inclusion Criteria:

• Severe congenital blepharoptosis

• Poor levator muscle function

• No previous ptosis surgery

Exclusion Criteria:

• Patients with Jaw winking phenomenon

• Blepharophimosis syndrome

• Congenital myasthenia

Related Conditions & MeSH terms

• Blepharoptosis

Intervention

Procedure:
• Ptosis surgery
Frontalis sling surgery using pose-up and Wright's fascia-lata needle

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Minya	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of ptosis	The average marginal reflex distance was improved from -0.8 mm preoperative to +2.73 mm after 3 months	3 months