Clinical Significance of Whitnall Ligament Structure

• Conditions: Congenital Ptosis
• Interventions: Procedure: Levator resection

• Registration Number: NCT04537169
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-18
• Study Start: 2020-08-20
• Study First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Study First Posted: 2020-09-03
• Last Update Posted: 2020-09-03
• Primary Completion: 2021-08
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Congenital ptosis

Exclusion Criteria

• Previous ptosis surgery
• Non congenital ptosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe congenital ptosis	Levator resection	children with severe congenital ptosis
Mild congenital ptosis	Levator resection	children with mild congenital ptosis
Moderate congenital ptosis	Levator resection	children with moderate congenital ptosis

Primary Outcome Measures

Name	Time	Method
Success of levator resection in relation to structure of Whitnall ligament	An average of 1 year	Relating the structure of the ligament with the degree of severity of ptosis by studying its position, shape and tightness in all cases during surgery

Trial Locations

Locations (1)

Ophthalmology Department, Menoufia University Hospital; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt