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Completed

NCT Number: NCT03240107

Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis

to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis

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Key information

Conditions

Congenital Ptosis

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HEBA

Cairo, Zahraa AL Maadi, Egypt

About this study

Target population for the study is children under twelve years old presenting to ophthalmology clinic at Cairo university specialized pediatric hospital with congenital ptosis.

Patients will be randomly divided into two groups First group (A) will contain 20 patients who will undergo standard levator aponeurosis resection Second group (B) will contain 20 patient who will undergo two point fixation levator tucking

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Unilateral or bilateral simple isolated congenital ptosis.
  • Levator function more than 4mm

Exclusion criteria

  • Congenital ptosis associated with other ocular syndromes.
  • Recurrent ptosis following any attempt for repair.
  • Traumatic ptosis or acquired ptosis
  • -ve bell's phenomenon.

Treatment and study plan

levator resection

Procedure

The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.

The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect.

The skin incision closed by continuous suture with 6-0 prolene.

levator tucking

Procedure

The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.

. The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene.

Primary outcomes

  1. Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1

    Time frame: 6 to 9 months

    MRD1:distance between upper lid margin and corneal light reflex measured in mm by transparent ruler

Sponsors and collaborators

Lead sponsor

Heba Hamdy Ibrahim Mohammed

Other

Registry information

Official study title

Standard Levator Aponeurosis / Muscle Resection With Three Point Fixation Versus Two Point Fixation Tucking for Congenital Ptosis With Fair to Good Levator Function

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2017
Registry last updated
Aug 4, 2017

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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