Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication

Not Applicable

Not yet recruiting

• Conditions: Congenital Ptosis
• Interventions: Procedure: levator muscle plication; Procedure: levator muscle resection

• Registration Number: NCT05895695
• Lead Sponsor: Sohag University

Brief Summary

The aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis.

Detailed Description

Blepharotosis is one of the most encountered oculoplastic problems. Blepharoptosis is an abnormal low lying upper eyelid margin more than 2mm below the superior corneal limbus in the primary gaze position.

It can be subdivided according to the amount of levator function into poor (0-5),fair (6-11) or good (12 or more) millimeter. It can be classified also according to the degree of ptosis into mild (2mm) moderate (3mm) and severe ( 4mm or more). Surgical options for each of these groups are based on levator function as well as the degree and the cause of ptosis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-05-11
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-06
• Last Update Submitted: 2023-06-06
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-08
• Study Start: 2023-07
• Primary Completion: 2024-01
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• mild to moderate simple unilateral congenital ptosis with good to fair levator function

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Exclusion Criteria

1. severe ptosis
2. poor levator function
3. poor Bell's phenomenon
4. lagophthalmos
5. diminished corneal sensation
6. completed congenital or acquired ptosis
7. history of previous lid surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	levator muscle plication	evaluation of levator muscle plication on congenital ptosis
1	levator muscle resection	evaluation of levator muscle resection on congenital ptosis

Primary Outcome Measures

Name	Time	Method
Comparison of outcome of levator muscle resection and plication in mild to moderate congenital ptosis	6 months	Comparison of surgical efficacy of levator muscle resection and plication regarding lid height as measured by MRD 1

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt