NCT05358002

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 20, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

April 9, 2022

Last Update Submit

April 27, 2022

Conditions

Unrecognized Condition

Outcome Measures

Primary Outcomes (1)

  • Improvement of MRD ( marginal reflex distance )

    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

    About 6 months

Secondary Outcomes (1)

  • Improvement of the vertical palpebral fissure height

    6 months

Study Arms (2)

Frontalis sling

ACTIVE COMPARATOR

Connecting the frontalis muscle action with the tarsus of the upper eyelid with synthetic material PTFE ( gore-tex )

Procedure: Frontalis flap

Frontalis flap

EXPERIMENTAL

Fashonizing a flap from frontalis muscle and connecting it to the tarsus of the upper eyelid

Procedure: Frontalis flap

Interventions

Frontalis flapPROCEDURE

Fashonizing a flap from frontalis muscle and connecting it to the tarsus of the upper eyelid

Frontalis flapFrontalis sling

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • cases of congenital ptosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr al ainy

Cairo, 11865, Egypt

Location

Study Officials

  • Magda S Abdelaziz, Prof.

    Kasr alainy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 9, 2022

First Posted

May 3, 2022

Study Start

May 20, 2020

Primary Completion

April 9, 2022

Study Completion

April 9, 2022

Last Updated

May 3, 2022

Record last verified: 2022-04

Locations

EG(1)