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Comparative Study Between Frontalis Flap Advancement Versus Frontalis Sling Operations in Mangment of Congenital Blepharoptosis

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ClinicalTrials.gov Identifier: NCT05358002
Recruitment Status : Completed
First Posted : May 3, 2022
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Hesham Ibrahim Abd ElFattah Ibrahim Shahin, Cairo University

Brief Summary:
A prospective comparative study between the results obtained by applying frontalis muscle flap advancement and frontalis sling operations for correction of congenital ptosis with poor levator muscle function. Study will include evaluation of the functional and cosmetic results, recurrence rates, and the incidence and varieties of different complications between the two techniques

Condition or disease Intervention/treatment Phase
Unrecognized Condition Procedure: Frontalis flap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparative Study Between Frontalis Flap Advancement Versus Frontalis Sling Operations in Mangment of Congenital Blepharoptosis
Actual Study Start Date : May 20, 2020
Actual Primary Completion Date : April 9, 2022
Actual Study Completion Date : April 9, 2022

Arm Intervention/treatment
Active Comparator: Frontalis sling
Connecting the frontalis muscle action with the tarsus of the upper eyelid with synthetic material PTFE ( gore-tex )
Procedure: Frontalis flap
Fashonizing a flap from frontalis muscle and connecting it to the tarsus of the upper eyelid

Experimental: Frontalis flap
Fashonizing a flap from frontalis muscle and connecting it to the tarsus of the upper eyelid
Procedure: Frontalis flap
Fashonizing a flap from frontalis muscle and connecting it to the tarsus of the upper eyelid




Primary Outcome Measures :
  1. Improvement of MRD ( marginal reflex distance ) [ Time Frame: About 6 months ]
    Improvement of the marginal reflex distance that is measured by the ruler, which is the distance between the margin of the upper eyelid and the light reflex reflecting from the cornea from a torch against the cornea


Secondary Outcome Measures :
  1. Improvement of the vertical palpebral fissure height [ Time Frame: 6 months ]
    Measuring the distance between margin of the upper and lower eyelid using a ruler



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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • cases of congenital ptosis

Exclusion Criteria:

  • associated with other anomalies e.g: blepharophimosis syndrome , marcus gunn jaw winking.
  • previous ptosis surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05358002


Locations
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Egypt
Kasr al ainy
Cairo, Egypt, 11865
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Magda S Abdelaziz, Prof. Kasr alainy
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Responsible Party: Hesham Ibrahim Abd ElFattah Ibrahim Shahin, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT05358002    
Other Study ID Numbers: MD-93-2020
First Posted: May 3, 2022    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blepharoptosis
Eyelid Diseases
Eye Diseases