Clinical Significance of Whitnall Ligament Structure

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.

Study Overview

• Status: Unknown
• Conditions: Congenital Ptosis
• Intervention / Treatment: Procedure: Levator resection

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 Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt
      • Recruiting
      • Ophthalmology Department, Menoufia University Hospital
      • Contact: Hoda M El Sobky, PhD; Phone Number: 0020 01210804240; Email: elsobky.hoda@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with congenital ptosis

Description

Inclusion Criteria:

• Congenital ptosis

Exclusion Criteria:

• Previous ptosis surgery
• Non congenital ptosis

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mild congenital ptosis; children with mild congenital ptosis	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
Moderate congenital ptosis; children with moderate congenital ptosis	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
Severe congenital ptosis; children with severe congenital ptosis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Chair: Richard C Allen, Department of Ophthalmology, Cullen Eye Institute,

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2020
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (ACTUAL): September 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: levator resection; Whitnall ligament; congenital ptosis
• Additional Relevant MeSH Terms: Eye Diseases; Pathological Conditions, Anatomical; Eyelid Diseases; Prolapse; Blepharoptosis
• Other Study ID Numbers: OPHTH2/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No