Management of Severe Congenital Blepharoptosis

Not Applicable

Completed

• Conditions: Blepharoptosis
• Interventions: Procedure: Ptosis surgery

• Registration Number: NCT04214379
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2018-03-10
• Study Completion: 2018-09-17
• Status Verified: 2019-12
• Study First Submitted: 2019-12-28
• Study First Submitted QC: 2019-12-28
• Last Update Submitted: 2019-12-31
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
severe congenital ptosis	Ptosis surgery	Patients with severe congenital ptosis with poor levator muscle function

Primary Outcome Measures

Name	Time	Method
Improvement of ptosis	3 months	The average marginal reflex distance was improved from -0.8 mm preoperative to +2.73 mm after 3 months

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Minya, Minia, Egypt