NCT04537169

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

August 18, 2020

Last Update Submit

August 28, 2020

Conditions

Congenital Ptosis

Keywords

Whitnall ligamentcongenital ptosislevator resection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Mild congenital ptosis

children with mild congenital ptosis

Procedure: Levator resection

Moderate congenital ptosis

children with moderate congenital ptosis

Procedure: Levator resection

Severe congenital ptosis

children with severe congenital ptosis

Procedure: Levator resection

Interventions

Levator resectionPROCEDURE

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

Mild congenital ptosisModerate congenital ptosisSevere congenital ptosis

Eligibility Criteria

Age2 Years - 16 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsCaucasian
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patients with congenital ptosis

You may qualify if:

  • Congenital ptosis

You may not qualify if:

  • Previous ptosis surgery
  • Non congenital ptosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department, Menoufia University Hospital

Shibīn al Kawm, Menoufia, Egypt

RECRUITING

Study Officials

  • Richard C Allen

    Department of Ophthalmology, Cullen Eye Institute,

    STUDY CHAIR

Central Study Contacts

Sameh S Mandour, M.D.

CONTACT

01113139138dr_ssmandour@hotmail.com

Mostafa M Diab, M.D.

CONTACT

01016737314mmd11@fayoum.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

August 18, 2020

First Posted

September 3, 2020

Study Start

August 20, 2020

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

September 3, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)