Clinical Significance of Whitnall Ligament Structure

Sponsor
Menoufia University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04537169
Collaborator
(none)
45
1
12.4
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Clinical Significance of Whitnall Ligament Structure in Patients With Congenital Ptosis
Actual Study Start Date :
Aug 20, 2020
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Congenital ptosis
Exclusion Criteria:
  • Previous ptosis surgery

  • Non congenital ptosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ophthalmology Department, Menoufia University Hospital Shibīn Al Kawm Menoufia Egypt

Sponsors and Collaborators

  • Menoufia University

Investigators

  • Study Chair: Richard C Allen, Department of Ophthalmology, Cullen Eye Institute,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sameh S. Mandour, Assistant Professor of Ophthalmology, Menoufia University
ClinicalTrials.gov Identifier:
NCT04537169
Other Study ID Numbers:
  • OPHTH2/2020
First Posted:
Sep 3, 2020
Last Update Posted:
Sep 3, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sameh S. Mandour, Assistant Professor of Ophthalmology, Menoufia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 3, 2020