Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-31 @ 7:18 AM
Study NCT ID:
NCT04537169
Status:
UNKNOWN
Last Update Posted:
2020-09-03
First Post:
2020-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Significance of Whitnall Ligament Structure
Sponsor:
Menoufia University
Organization:
Study Overview
Official Title:
Clinical Significance of Whitnall Ligament Structure in Patients With Congenital Ptosis
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: