Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
45 participants
OBSERVATIONAL
2020-08-20
2021-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Mild congenital ptosis
children with mild congenital ptosis
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non congenital ptosis
2 Years
16 Years
ALL
No
Sponsors
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Menoufia University
OTHER
Responsible Party
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Sameh S. Mandour
Assistant Professor of Ophthalmology
Principal Investigators
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Richard C Allen
Role: STUDY_CHAIR
Department of Ophthalmology, Cullen Eye Institute,
Locations
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Ophthalmology Department, Menoufia University Hospital
Shibīn al Kawm, Menoufia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OPHTH2/2020
Identifier Type: -
Identifier Source: org_study_id
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