Surgical Management of Blepharoptosis

Blepharoptosis Clinical Trial

Official title:

Fixed Versus Adjustable Sutures in Management of Blepheroptosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03149367
• Other study ID #: 7540
• Status: Active, not recruiting
• Phase: N/A
• First received: May 8, 2017
• Last updated: May 10, 2017
• Start date: March 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: September 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Blepharoptosis

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Assuit university hospital	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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