NCT03240107

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
Last Updated

August 4, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

December 16, 2016

Last Update Submit

August 3, 2017

Conditions

Congenital Ptosis

Keywords

levator resectionlevator tuckingFair levator functionEyelid contour

Outcome Measures

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

    6 to 9 months

Study Arms (2)

levator resection

ACTIVE COMPARATOR

20 patients who will undergo levator aponeurosis resection technique

Procedure: levator resection

levator tucking

ACTIVE COMPARATOR

20 patients who will undergo two point fixation levator tucking technique

Procedure: levator tucking

Interventions

levator resectionPROCEDURE

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 resection
levator tuckingPROCEDURE

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.

levator tucking

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HEBA

Cairo, Zahraa AL Maadi, Egypt

Location

Study Officials

  • RANIA AS EL ASSAWY, PhD

    Cairo University

    STUDY CHAIR

  • Sameh HA ABDEL BAKY, MD

    Cairo University

    STUDY DIRECTOR

  • DINA HO HASSANIEN, MD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor heba hamdy ibrahim

Study Record Dates

First Submitted

December 16, 2016

First Posted

August 4, 2017

Study Start

May 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 4, 2017

Record last verified: 2017-07

Locations

EG(1)