CClinicalTrials.gg
CompletedNCT03240107Updated Aug 4, 2017

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

An interventional study of levator resection and levator tucking in Congenital Ptosis, sponsored by Heba Hamdy Ibrahim Mohammed. Completed at 1 site in Egypt. Open to participants aged 2 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by Heba Hamdy Ibrahim Mohammed · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
2 Years to 12 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Congenital Ptosis

Keywords

  • levator resection
  • levator tucking
  • Fair levator function
  • Eyelid contour
03

In context

Blepharoptosis

58 studies on the registry are indexed under Blepharoptosis; 16 are open to participants now.

This study's enrollment of 40 is below the median of 46 across 47 interventional studies indexed under Blepharoptosis.

Browse Blepharoptosis studies →

Lead sponsor

This is the only study on the registry with Heba Hamdy Ibrahim Mohammed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Congenital ptosis associated with other ocular syndromes.
  2. Recurrent ptosis following any attempt for repair.
  3. Traumatic ptosis or acquired ptosis
  4. -ve bell's phenomenon.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    levator resection

    20 patients who will undergo levator aponeurosis resection technique

    Procedure: levator resection

  • Active comparator
    levator tucking

    20 patients who will undergo two point fixation levator tucking technique

    Procedure: levator tucking

Interventions

  • Procedurelevator resection

    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.

  • Procedurelevator tucking

    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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: 6 to 9 months

07

Study locations

1 site
  • HEBA
    Cairo City, Zahraa AL Maadi, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03240107
Lead sponsor
Heba Hamdy Ibrahim Mohammed
Responsible party
Heba Hamdy Ibrahim Mohammed (Doctor heba hamdy ibrahim, Cairo University) — Sponsor-investigator
First posted
Aug 4, 2017
Start date
May 2016
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Aug 4, 2017

Study contacts

RANIA AS EL ASSAWY, PhD
study chair · Cairo University
Sameh HA ABDEL BAKY, MD
study director · Cairo University
DINA HO HASSANIEN, MD
study director · Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion