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

NCT ID: NCT05895695

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-02-29

Brief Summary

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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

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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.

Conditions

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Congenital Ptosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

evaluation of levator muscle resection on congenital ptosis

Group Type ACTIVE_COMPARATOR

levator muscle resection

Intervention Type PROCEDURE

resection of levator muscle in congenital unilateral ptosis

2

evaluation of levator muscle plication on congenital ptosis

Group Type ACTIVE_COMPARATOR

levator muscle plication

Intervention Type PROCEDURE

plication of levator muscle in congenital unilateral ptosis

Interventions

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levator muscle resection

resection of levator muscle in congenital unilateral ptosis

Intervention Type PROCEDURE

levator muscle plication

plication of levator muscle in congenital unilateral ptosis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Maggi Hosam Wasily

resident ophthalmology department el helal hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Maggi h Shaker, MBBCH

Role: CONTACT

01286773334

Islam a Aboellil, lecturer

Role: CONTACT

01006429637

Facility Contacts

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magdy m amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 24657037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26468822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23869256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12142765 (View on PubMed)

Other Identifiers

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Soh-Med-23-03-01MS

Identifier Type: -

Identifier Source: org_study_id

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