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

Primary Purpose

Congenital Ptosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
levator resection
levator tucking
Sponsored by
Heba Hamdy Ibrahim Mohammed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Ptosis focused on measuring levator resection, levator tucking, Fair levator function, Eyelid contour

Eligibility Criteria

2 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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.

Sites / Locations

  • HEBA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

levator resection

levator tucking

Arm Description

20 patients who will undergo levator aponeurosis resection technique

20 patients who will undergo two point fixation levator tucking technique

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 16, 2016
Last Updated
August 3, 2017
Sponsor
Heba Hamdy Ibrahim Mohammed
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1. Study Identification

Unique Protocol Identification Number
NCT03240107
Brief Title
Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis
Official Title
Standard Levator Aponeurosis / Muscle Resection With Three Point Fixation Versus Two Point Fixation Tucking for Congenital Ptosis With Fair to Good Levator Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heba Hamdy Ibrahim Mohammed

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Ptosis
Keywords
levator resection, levator tucking, Fair levator function, Eyelid contour

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
levator resection
Arm Type
Active Comparator
Arm Description
20 patients who will undergo levator aponeurosis resection technique
Arm Title
levator tucking
Arm Type
Active Comparator
Arm Description
20 patients who will undergo two point fixation levator tucking technique
Intervention Type
Procedure
Intervention Name(s)
levator resection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
levator tucking
Intervention Description
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 Outcome Measure Information:
Title
Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1
Description
MRD1:distance between upper lid margin and corneal light reflex measured in mm by transparent ruler
Time Frame
6 to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RANIA AS EL ASSAWY, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sameh HA ABDEL BAKY, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
DINA HO HASSANIEN, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
HEBA
City
Cairo City
State/Province
Zahraa AL Maadi
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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