Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04537169
Status:
UNKNOWN
Last Update Posted:
2020-09-03
First Post:
2020-08-18
Brief Title:
Clinical Significance of Whitnall Ligament Structure
Sponsor:
Menoufia University
Organization:
Menoufia University
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 Whitnalls 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 Whitnalls 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:
None
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?:
None