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

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

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

Study Overview

• Status: Completed
• Conditions: Congenital Ptosis
• Intervention / Treatment: Procedure: levator resection; Procedure: levator tucking

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zahraa AL Maadi
    • Cairo City, Zahraa AL Maadi, Egypt
      • Heba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: levator resection; 20 patients who will undergo levator aponeurosis resection technique	Procedure: levator 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.
Active Comparator: levator tucking; 20 patients who will undergo two point fixation levator tucking technique	Procedure: levator 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Heba Hamdy Ibrahim Mohammed
• Investigators: Study Chair: RANIA AS EL ASSAWY, PhD, Cairo University; Study Director: Sameh HA ABDEL BAKY, MD, Cairo University; Study Director: DINA HO HASSANIEN, MD, Cairo University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: levator resection; levator tucking; Fair levator function; Eyelid contour
• Additional Relevant MeSH Terms: Eye Diseases; Pathological Conditions, Anatomical; Eyelid Diseases; Prolapse; Blepharoptosis
• Other Study ID Numbers: hhim123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided