Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
Levator Muscle Resection for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
Shorter than P25 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
First Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedJune 8, 2023
June 1, 2023
6 months
May 11, 2023
June 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
1
ACTIVE COMPARATORevaluation of levator muscle resection on congenital ptosis
2
ACTIVE COMPARATORevaluation of levator muscle plication on congenital ptosis
Interventions
Eligibility Criteria
You may qualify if:
- mild to moderate simple unilateral congenital ptosis with good to fair levator function
You may not qualify if:
- severe ptosis
- poor levator function
- poor Bell's phenomenon
- lagophthalmos
- diminished corneal sensation
- completed congenital or acquired ptosis
- history of previous lid surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag University Hospital
Sohag, Egypt
Related Publications (4)
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.
PMID: 24657037BACKGROUNDNemet AY. Accuracy of Marginal Reflex Distance Measurements in Eyelid Surgery. J Craniofac Surg. 2015 Oct;26(7):e569-71. doi: 10.1097/SCS.0000000000001304.
PMID: 26468822BACKGROUNDHwang 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.
PMID: 23869256BACKGROUNDBaldwin 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.
PMID: 12142765BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident ophthalmology department el helal hospital
Study Record Dates
First Submitted
May 11, 2023
First Posted
June 8, 2023
Study Start
July 1, 2023
Primary Completion
January 1, 2024
Study Completion
February 1, 2024
Last Updated
June 8, 2023
Record last verified: 2023-06