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Surgical Management of Blepharoptosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149367
Recruitment Status : Unknown
Verified May 2017 by Noha Ali Essameldeen Mohamed Ali, Assiut University.
Recruitment status was:  Active, not recruiting
First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Noha Ali Essameldeen Mohamed Ali, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blepharoptosis Procedure: levator muscle resection with fixed sutures technique Procedure: Levator muscle resection with adjustable sutures technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fixed Versus Adjustable Sutures in Management of Blepheroptosis
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : September 1, 2019

Arm Intervention/treatment
Experimental: Fixed suture Procedure: 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

Experimental: Adjustable suture 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.




Primary Outcome Measures :
  1. The cosmetic appearance [ Time Frame: One week ]
    Symmetry of the two eyelids was calculated based on the difference in the margin reflex distance between them in the primary position of gaze. The results were classified into good, fair, and poor



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149367


Locations
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Egypt
Assuit university hospital
Assuit, Egypt, 71515
Sponsors and Collaborators
Assiut University
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Responsible Party: Noha Ali Essameldeen Mohamed Ali, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03149367    
Other Study ID Numbers: 7540
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blepharoptosis
Eyelid Diseases
Eye Diseases