Clinical Significance of Whitnall Ligament Structure

Congenital Ptosis Clinical Trial

Official title:

Clinical Significance of Whitnall Ligament Structure in Patients With Congenital Ptosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537169
• Other study ID #: OPHTH2/2020
• Status: Recruiting
• Start date: August 20, 2020
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: Menoufia University
• Contact: Sameh S Mandour, M.D.
• Phone: 01113139138
• Email: dr_ssmandour[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Congenital ptosis

Exclusion Criteria:

• Previous ptosis surgery

• Non congenital ptosis

Related Conditions & MeSH terms

• Blepharoptosis
• Congenital Ptosis
• Prolapse

Intervention

Procedure:
• Levator resection
Eyelid crease incision Dissection of the levator aponeurosis to the level of Whitnall ligament. Assessment of the structure of Whitnal ligament. Resection of a calculated part of the aponsurosis. re-attachment of the aponeurosis to the tarsus Incision closure with crease formation

Locations

Country	Name	City	State
Egypt	Ophthalmology Department, Menoufia University Hospital	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of levator resection in relation to structure of Whitnall ligament	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	An average of 1 year