search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharoptosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 8, 2017
Last Updated
May 10, 2017
Sponsor
Assiut University
search

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

Learn more about this trial

Surgical Management of Blepharoptosis

We'll reach out to this number within 24 hrs