Surgical Management of Blepharoptosis
Primary Purpose
Blepharoptosis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
levator muscle resection with fixed sutures technique
Levator muscle resection with adjustable sutures technique
Sponsored by
About this trial
This is an interventional treatment trial for Blepharoptosis
Eligibility 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.
Sites / Locations
- Assuit university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fixed suture
Adjustable suture
Arm Description
Outcomes
Primary Outcome Measures
The cosmetic appearance
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03149367
Brief Title
Surgical Management of Blepharoptosis
Official Title
Fixed Versus Adjustable Sutures in Management of Blepheroptosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fixed suture
Arm Type
Experimental
Arm Title
Adjustable suture
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
levator muscle resection with fixed sutures technique
Intervention Description
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
Intervention Name(s)
Levator muscle resection with adjustable sutures technique
Intervention Description
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 Measure Information:
Title
The cosmetic appearance
Description
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
Time Frame
One week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Assuit university hospital
City
Assuit
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
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Surgical Management of Blepharoptosis
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