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Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis

Standard Levator Aponeurosis / Muscle Resection With Three Point Fixation Versus Two Point Fixation Tucking for Congenital Ptosis With Fair to Good Levator Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03240107
Enrollment
40
Registered
2017-08-04
Start date
2016-05-31
Completion date
2017-07-31
Last updated
2017-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Ptosis

Keywords

levator resection, levator tucking, Fair levator function, Eyelid contour

Brief summary

to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis

Detailed description

Target population for the study is children under twelve years old presenting to ophthalmology clinic at Cairo university specialized pediatric hospital with congenital ptosis. Patients will be randomly divided into two groups First group (A) will contain 20 patients who will undergo standard levator aponeurosis resection Second group (B) will contain 20 patient who will undergo two point fixation levator tucking

Interventions

The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva. The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect. The skin incision closed by continuous suture with 6-0 prolene.

PROCEDURElevator tucking

The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva. . The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene.

Sponsors

Heba Hamdy Ibrahim Mohammed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

1. Unilateral or bilateral simple isolated congenital ptosis. 2. Levator function more than 4mm

Exclusion criteria

1. Congenital ptosis associated with other ocular syndromes. 2. Recurrent ptosis following any attempt for repair. 3. Traumatic ptosis or acquired ptosis 4. -ve bell's phenomenon.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD16 to 9 monthsMRD1:distance between upper lid margin and corneal light reflex measured in mm by transparent ruler

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026