Clinical Significance of Whitnall Ligament Structure

M

Menoufia University

Status

Unknown

Conditions

Congenital Ptosis

Treatments

Procedure: Levator resection

Study type

Observational

Funder types

Other

Identifiers

NCT04537169
OPHTH2/2020

Details and patient eligibility

About

Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Congenital ptosis

Exclusion criteria

  • Previous ptosis surgery
  • Non congenital ptosis

Trial design

45 participants in 3 patient groups

Mild congenital ptosis
Description:
children with mild congenital ptosis
Treatment:
Procedure: Levator resection
Moderate congenital ptosis
Description:
children with moderate congenital ptosis
Treatment:
Procedure: Levator resection
Severe congenital ptosis
Description:
children with severe congenital ptosis
Treatment:
Procedure: Levator resection

Trial contacts and locations

1

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Central trial contact

Mostafa M Diab, M.D.; Sameh S Mandour, M.D.

Data sourced from clinicaltrials.gov

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