Congenital Ptosis Clinical Trial
Official title:
Clinical Significance of Whitnall Ligament Structure in Patients With Congenital Ptosis
Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.
The study will be a prospective obsevational study. It will include patients (2-16 years old)
who will undergo levator resection for simple congenital ptosis correction in Ophthalmology
Department of Menoufia University Hospital.
Patients will be divided into 3 groups, 15 patients in each. Group I for mild ptosis, Group
II for moderate ptosis Group 3 for severe ptosis.
Exclusion criteria included any patients with previous ptosis or any eyelid surgery and
patients with a non congenital ptosis.
Patients included in the study well be informed about the research and the surgical maneuver
which will be used with full discussion of all details regarding the postoperative follow up
and the potential complications. A written consent in Arabic will then be taken from the
parents of the patients
Preoperative assessment will include Complete ophthalmological examination including; Margin
to Reflex Distance 1 (MRD1), Vertical Fissure Height (VFH), Levator function (LF), and eyelid
crease shape and position.
Intraoperative assessment will include Whitnall ligament structure assessment including:
- The level (the length from the insertion of the levator aponeurosis to Whitnall's
ligament)
- Shape (definite band-like, weak string, undifferentiated)
- Tightness.
Postoperative assessment will be on scheduled visits at first week, one month, 3 months and 6
months postoperatively and will include MRD1, VFH, LF, and lagophthalmos measurements
Results will be documented and tabulated and statistically managed.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03240107 -
Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis
|
N/A | |
| Not yet recruiting |
NCT05895695 -
Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
|
N/A |