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Completed

NCT Number: NCT04214379

Management of Severe Congenital Blepharoptosis

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

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Key information

Conditions

Blepharoptosis Eye Diseases Eyelid Diseases

Age range

11 month–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Minya, Minya Governorate, 61111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ptosis surgery

Procedure

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

Primary outcomes

  1. Improvement of ptosis

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 2, 2020
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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