Surgical Management of Blepharoptosis
Fixed Versus Adjustable Sutures in Management of Blepheroptosis
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 8, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMay 11, 2017
May 1, 2017
2 years
May 8, 2017
May 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
One week
Study Arms (2)
Fixed suture
EXPERIMENTALAdjustable suture
EXPERIMENTALInterventions
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
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.
Eligibility Criteria
You may qualify if:
- Cases of blepharoptosis admitted at Assiut University Hospital.
- Cases that are fit for surgery.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assuit university hospital
Asyut, 71515, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
May 8, 2017
First Posted
May 11, 2017
Study Start
March 1, 2017
Primary Completion
March 1, 2019
Study Completion
September 1, 2019
Last Updated
May 11, 2017
Record last verified: 2017-05