Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication

Congenital Ptosis Clinical Trial

Official title:

Levator Muscle Resection for Unilateral Congenital Ptosis Repair as Compared to Levator Plication

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05895695
• Other study ID #: Soh-Med-23-03-01MS
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: February 2024

Study information

• Verified date: June 2023
• Source: Sohag University
• Contact: Maggi h Shaker, MBBCH
• Phone: 01286773334
• Email: magi_shaker[@]med.Sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis.

Description:

Blepharotosis is one of the most encountered oculoplastic problems. Blepharoptosis is an abnormal low lying upper eyelid margin more than 2mm below the superior corneal limbus in the primary gaze position.

It can be subdivided according to the amount of levator function into poor (0-5),fair (6-11) or good (12 or more) millimeter. It can be classified also according to the degree of ptosis into mild (2mm) moderate (3mm) and severe ( 4mm or more). Surgical options for each of these groups are based on levator function as well as the degree and the cause of ptosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• mild to moderate simple unilateral congenital ptosis with good to fair levator function

Exclusion Criteria:

1. severe ptosis

2. poor levator function

3. poor Bell's phenomenon

4. lagophthalmos

5. diminished corneal sensation

6. completed congenital or acquired ptosis

7. history of previous lid surgery

Related Conditions & MeSH terms

• Blepharoptosis
• Congenital Ptosis
• Prolapse

Intervention

Procedure:
• levator muscle resection
resection of levator muscle in congenital unilateral ptosis
• levator muscle plication
plication of levator muscle in congenital unilateral ptosis

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Baldwin HC, Manners RM. Congenital blepharoptosis: a literature review of the histology of levator palpebrae superioris muscle. Ophthalmic Plast Reconstr Surg. 2002 Jul;18(4):301-7. doi: 10.1097/01.IOP.0000021973.72318.07. — View Citation

Hwang K. Surgical anatomy of the upper eyelid relating to upper blepharoplasty or blepharoptosis surgery. Anat Cell Biol. 2013 Jun;46(2):93-100. doi: 10.5115/acb.2013.46.2.93. Epub 2013 Jun 30. — View Citation

Nemet AY. Accuracy of Marginal Reflex Distance Measurements in Eyelid Surgery. J Craniofac Surg. 2015 Oct;26(7):e569-71. doi: 10.1097/SCS.0000000000001304. — View Citation

SooHoo JR, Davies BW, Allard FD, Durairaj VD. Congenital ptosis. Surv Ophthalmol. 2014 Sep-Oct;59(5):483-92. doi: 10.1016/j.survophthal.2014.01.005. Epub 2014 Feb 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of outcome of levator muscle resection and plication in mild to moderate congenital ptosis	Comparison of surgical efficacy of levator muscle resection and plication regarding lid height as measured by MRD 1	6 months