## Protocol Section
### Identification Module
**NCT ID:** NCT04214379

**Brief Title:** Management of Severe Congenital Blepharoptosis

**Official Title:** Evaluation of Polytetrafluoroethylene (Ptose-up) in Management of Severe Congenital Blepharoptosis

#### Organization Study ID Info
**ID:** Oculoplastic Unit
#### Organization
**Class:** OTHER
**Full Name:** Minia University
### Status Module
#### Completion Date
**Date:** 2018-09-17

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-01-03

**Type:** ACTUAL

**Last Update Submit Date:** 2019-12-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-03-10

**Type:** ACTUAL

#### Start Date
**Date:** 2017-02-01

**Type:** ACTUAL

**Status Verified Date:** 2019-12

#### Study First Post Date
**Date:** 2020-01-02
**Type:** ACTUAL
**Study First Submit Date:** 2019-12-28
**Study First Submit QC Date:** 2019-12-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Minia University

#### Responsible Party

**Investigator Affiliation:** Minia University

**Investigator Full Name:** Mohamed Farag Khalil Ibrahiem

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Blepharoptosis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 15

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with severe congenital ptosis with poor levator muscle function

**Intervention Names:**

- Procedure: Ptosis surgery

**Label:** severe congenital ptosis

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- severe congenital ptosis

**Description:** Frontalis sling surgery using pose-up and Wright's fascia-lata needle

**Name:** Ptosis surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The average marginal reflex distance was improved from -0.8 mm preoperative to +2.73 mm after 3 months

**Measure:** Improvement of ptosis

**Time Frame:** 3 months

### Eligibility Module

**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

**Maximum Age:** 9 Years

**Minimum Age:** 11 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Minya

**Country:** Egypt

**Facility:** Faculty of Medicine

**State:** Minia

**Zip:** 61111

#### Overall Officials

**Official 1:**

**Affiliation:** Minia University

**Name:** Mohamed F Ibrahiem, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005141

- Term: Eyelid Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5044

- Name: Blepharoptosis

- Relevance: HIGH

- As Found: Blepharoptosis

- ID: M8284

- Name: Eyelid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001763

- Term: Blepharoptosis

### Misc Info Module

- Version Holder: 2024-05-24
