NCT04214379

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

December 28, 2019

Last Update Submit

December 31, 2019

Conditions

Blepharoptosis

Outcome Measures

Primary Outcomes (1)

  • Improvement of ptosis

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

    3 months

Study Arms (1)

severe congenital ptosis

OTHER

Patients with severe congenital ptosis with poor levator muscle function

Procedure: Ptosis surgery

Interventions

Ptosis surgeryPROCEDURE

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

severe congenital ptosis

Eligibility Criteria

Age11 Months - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Mohamed F Ibrahiem, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 28, 2019

First Posted

January 2, 2020

Study Start

February 1, 2017

Primary Completion

March 10, 2018

Study Completion

September 17, 2018

Last Updated

January 3, 2020

Record last verified: 2019-12

Locations

EG(1)