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

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

Detailed Description
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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

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

Conditions
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Congenital Ptosis

Intervention / Treatment
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* Procedure: levator resection
* Procedure: levator tucking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: levator resection<br>20 patients who will undergo levator aponeurosis resection technique | Procedure: levator resection<br>* 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.<br>|
| Active Comparator: levator tucking<br>20 patients who will undergo two point fixation levator tucking technique | Procedure: levator tucking<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levator resection, levator tucking, Fair levator function, Eyelid contour