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

Congenital Ptosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240107
• Other study ID #: hhim123
• Status: Completed
• Phase: N/A
• First received: December 16, 2016
• Last updated: August 3, 2017
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blepharoptosis
• Congenital Ptosis
• Prolapse

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	HEBA	Cairo city	Zahraa Al Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Heba Hamdy Ibrahim Mohammed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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