Surgical Management of Blepharoptosis

NCT ID: NCT03149367

Last Updated: 2017-05-11

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-09-01

Brief Summary

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Comparison of the results of levator resection operation with the use of fixed sutures technique in which the levator muscle is approached through skin incision and the muscle shortened and sutured directly to the tarsus then the skin crease reformed with interrupted sutures which pick up the underlying levator muscle versus the results with the use of adjustable sutures in which the suture passes through the levator muscle into the tarsal plate and out through the skin edge .the skin crease is formed separately so that adjusting the suture doesn't open the wound, the suture can be adjusted according to the result up to 4 days post operative.

Detailed Description

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Conditions

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Blepharoptosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fixed suture

Group Type EXPERIMENTAL

levator muscle resection with fixed sutures technique

Intervention Type PROCEDURE

The levator muscle is approached through skin incision and the muscle shortened and sutured directly to the tarsus then the skin crease reformed with interrupted sutures which pick up the underlying levator muscle

Adjustable suture

Group Type EXPERIMENTAL

Levator muscle resection with adjustable sutures technique

Intervention Type PROCEDURE

The adjustable sutures technique in which the sutures passes through the levator muscle into the tarsal plate and out through the skin edge .the skin crease is formed separately so that adjusting the suture doesn't open the wound, the suture can be adjusted according to the result up to 4 days post operative.

Interventions

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levator muscle resection with fixed sutures technique

The levator muscle is approached through skin incision and the muscle shortened and sutured directly to the tarsus then the skin crease reformed with interrupted sutures which pick up the underlying levator muscle

Intervention Type PROCEDURE

Levator muscle resection with adjustable sutures technique

The adjustable sutures technique in which the sutures passes through the levator muscle into the tarsal plate and out through the skin edge .the skin crease is formed separately so that adjusting the suture doesn't open the wound, the suture can be adjusted according to the result up to 4 days post operative.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Cases of blepharoptosis admitted at Assiut University Hospital.
* Cases that are fit for surgery.

Exclusion Criteria

* Cases not fit for surgery.
* Cases of pseudoptosis may result from many conditions that simulate an asymmetry of the upper eyelid level. Dysthyroid ophthalmopathy, enophthalmos, or exophthalmos can accentuate a minimal blepharoptosis or produce the appearance of blepharoptosis on the contralateral normal side,
* Cases with diseases, such as myasthenia gravis; negativity for Bell palsy symptoms; and Marcus Gunn jaw-winking syndrome.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Noha Ali Essameldeen Mohamed Ali

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assuit university hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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7540

Identifier Type: -

Identifier Source: org_study_id

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