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

Primary Purpose

Congenital Ptosis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

levator muscle resection

levator muscle plication

About this trial

This is an interventional treatment trial for Congenital Ptosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: mild to moderate simple unilateral congenital ptosis with good to fair levator function Exclusion Criteria: severe ptosis poor levator function poor Bell's phenomenon lagophthalmos diminished corneal sensation completed congenital or acquired ptosis history of previous lid surgery

Sites / Locations

Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

evaluation of levator muscle resection on congenital ptosis

evaluation of levator muscle plication on congenital ptosis

Outcomes

Primary Outcome Measures

Comparison of outcome of levator muscle resection and plication in mild to moderate congenital ptosis

Comparison of surgical efficacy of levator muscle resection and plication regarding lid height as measured by MRD 1

Secondary Outcome Measures

Full Information

NCT ID

NCT05895695

First Posted

May 11, 2023

Last Updated

June 6, 2023

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05895695

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 2023 (Anticipated)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Ptosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

evaluation of levator muscle resection on congenital ptosis

Arm Title

Arm Type

Active Comparator

Arm Description

evaluation of levator muscle plication on congenital ptosis

Intervention Type

Procedure

Intervention Name(s)

levator muscle resection

Intervention Description

resection of levator muscle in congenital unilateral ptosis

Intervention Type

Procedure

Intervention Name(s)

levator muscle plication

Intervention Description

plication of levator muscle in congenital unilateral ptosis

Primary Outcome Measure Information:

Title

Comparison of outcome of levator muscle resection and plication in mild to moderate congenital ptosis

Description

Comparison of surgical efficacy of levator muscle resection and plication regarding lid height as measured by MRD 1

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maggi h Shaker, MBBCH

Phone

01286773334

magi_shaker@med.Sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Islam a Aboellil, lecturer

Phone

01006429637

dr.islamophth@yahoo.com

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

magdy m amin, professor

12. IPD Sharing Statement

Citations:

PubMed Identifier

24657037

Citation

SooHoo JR, Davies BW, Allard FD, Durairaj VD. Congenital ptosis. Surv Ophthalmol. 2014 Sep-Oct;59(5):483-92. doi: 10.1016/j.survophthal.2014.01.005. Epub 2014 Feb 5.

Results Reference

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PubMed Identifier

26468822

Citation

Nemet AY. Accuracy of Marginal Reflex Distance Measurements in Eyelid Surgery. J Craniofac Surg. 2015 Oct;26(7):e569-71. doi: 10.1097/SCS.0000000000001304.

Results Reference

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PubMed Identifier

23869256

Citation

Hwang K. Surgical anatomy of the upper eyelid relating to upper blepharoplasty or blepharoptosis surgery. Anat Cell Biol. 2013 Jun;46(2):93-100. doi: 10.5115/acb.2013.46.2.93. Epub 2013 Jun 30.

Results Reference

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PubMed Identifier

12142765

Citation

Baldwin HC, Manners RM. Congenital blepharoptosis: a literature review of the histology of levator palpebrae superioris muscle. Ophthalmic Plast Reconstr Surg. 2002 Jul;18(4):301-7. doi: 10.1097/01.IOP.0000021973.72318.07.

Results Reference

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

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